Adapta™ ADSR01

• FDA PMA P980035 decided 29 Jan 1999 Active
• FDA GUDID UDI-DI 00643169708808 listed 24 Jun 2017 Listed

• 2 recalls, same reason

  • Ongoing Z-2128-2025 FDA Class II ·initiated 17 Jun 2025 ·on shared PMA P980035
  • Ongoing Z-2127-2025 FDA Class II ·initiated 17 Jun 2025 ·on shared PMA P980035

  A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.

• • Ongoing Z-1924-2025 FDA Class II ·initiated 29 Apr 2025

  Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or system revision (explant/replacement) leading to infection, hematoma, or temporary impairment.

• 4 recalls, same reason

  • Ongoing Z-2510-2020 FDA Class II ·initiated 4 Jun 2020
  • Ongoing Z-2509-2020 FDA Class II ·initiated 4 Jun 2020
  • Ongoing Z-2508-2020 FDA Class II ·initiated 4 Jun 2020
  • Ongoing Z-2507-2020 FDA Class II ·initiated 4 Jun 2020

  There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT"). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.

• 6 recalls, same reason

  • Ongoing Z-0811-2019 FDA Class I ·initiated 17 Jan 2019
  • Ongoing Z-0808-2019 FDA Class I ·initiated 17 Jan 2019
  • Ongoing Z-0810-2019 FDA Class I ·initiated 17 Jan 2019
  • Ongoing Z-0809-2019 FDA Class I ·initiated 17 Jan 2019
  • Ongoing Z-0806-2019 FDA Class I ·initiated 17 Jan 2019
  • Ongoing Z-0807-2019 FDA Class I ·initiated 17 Jan 2019

  A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality

• • Terminated Z-2120-2011 FDA Unclassified (pre-2012) ·initiated 4 Apr 2011

  A rare measurement lock-up condition that may (at a rate of approximately 1 in 18,000 devices) inappropriately trigger ERI/RRT in the Medtronic Dual Chamber Pacemakers: Kappa 600, 700, 800, 900, EnPulse, Adapta, Versa, Sensia. This is caused by a random lock-up of the measurement system hardware that may result in an incorrect battery voltage reading of zero. This issue does NOT impact battery lon

• • Terminated Z-1440-2010 FDA Unclassified (pre-2012) ·initiated 11 Feb 2010 ·on shared PMA P980035

  Medtronic is informing doctors of two specific battery issues with EnRhythm pacemakers that will be addressed by a Medtronic software update available mid-2010. If the software update referenced above is not implemented, there will be a potential risk of loss of device functionality or risk for loss of therapy at or near ERI in a small number of devices. The software will eliminate this issue, fo

• • Terminated Z-1515-2009 FDA Unclassified (pre-2012) ·initiated 18 May 2009

  One or more bond wire pairs will lift or separate from the bonding terminals on the device hybrid. This may present clinically as loss of rate response, premature battery depletion, loss of telemetry, or no output.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 17 Jan 2019 Recall initiated FDA recalls Z-0809-2019
2. 17 Jan 2019 Recall initiated FDA recalls Z-0806-2019
3. 17 Jan 2019 Recall initiated FDA recalls Z-0807-2019
4. 4 Jun 2020 Recall initiated FDA recalls Z-2510-2020
5. 4 Jun 2020 Recall initiated FDA recalls Z-2509-2020
6. 4 Jun 2020 Recall initiated FDA recalls Z-2508-2020
7. 4 Jun 2020 Recall initiated FDA recalls Z-2507-2020
8. 29 Apr 2025 Recall initiated FDA recalls Z-1924-2025
9. 17 Jun 2025 Recall initiated FDA recalls Z-2128-2025
10. 17 Jun 2025 Recall initiated FDA recalls Z-2127-2025

8 earlier events are in the sections above.

Trade name

Adapta™

Generic name

Single-chamber implantable pacemaker, rate-responsive

Model / reference

ADSR01

Primary DI / UDI-DI

00643169708808

PMA number

P980035 ↗

FDA product code

NVN, NVZ, LWP

GMDN term

Single-chamber implantable pacemaker, rate-responsive

Device class

Class III

GUDID distribution status

In Commercial Distribution

Category: Single-chamber implantable pacemaker, rate-responsive

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