Assurity™ PM1240

• FDA PMA P880086 decided 21 Aug 1989 Active
• FDA GUDID UDI-DI 05414734507066 listed 10 Apr 2017 Listed

• 2 recalls, same reason

  • Ongoing Z-1496-2022 FDA Class II ·initiated 17 Jun 2022 ·on shared PMA P880086
  • Ongoing Z-1497-2022 FDA Class II ·initiated 17 Jun 2022 ·on shared PMA P880086

  The Merlin" 2 PCS model MER3700 is a portable, dedicated programming system designed to interrogate, program, display data from, and test Abbott Medical implantable medical devices during implant and follow-up.

• • Ongoing Z-1495-2022 FDA Class II ·initiated 17 Jun 2022 ·on shared PMA P880086

  There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.

• • Terminated Z-0430-2012 FDA Unclassified (pre-2012) ·initiated 23 Sep 2011 ·on shared PMA P880086

  St. Jude Medical has received reports of out of range pacing lead impedance (PLI) measurements. These measurements are low and out of range (<200 ohms) but measure in range during visits to the clinic. The out of range readings are concluded as false.

• • Terminated Z-0429-2012 FDA Unclassified (pre-2012) ·initiated 23 Sep 2011 ·on shared PMA P880086

  St. Jude Medical has received reports of out of range pacing lead impedance (PLI) measurements.These measurements are low and out of range (<200 ohms) but measure in range during visits to the clinic. The out of range readings are concluded as false.

• 3 recalls, same reason

  • Terminated Z-0298-2007 FDA Unclassified (pre-2012) ·initiated 6 Oct 2006 ·on shared PMA P880086
  • Terminated Z-0296-2007 FDA Unclassified (pre-2012) ·initiated 6 Oct 2006 ·on shared PMA P880086
  • Terminated Z-0297-2007 FDA Unclassified (pre-2012) ·initiated 6 Oct 2006 ·on shared PMA P880086

  St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510 and Merlin PCS Model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and Elective Replacement Indicator (ERI) status.

• • Terminated Z-0052-04 FDA Unclassified (pre-2012) ·initiated 31 Jul 2003 ·on shared PMA P880086

  Under certain circumstances, pacemaker has a potential to deliver a short coupled pacing interval of approx. 300 msec (200ppm). It is also possible that a patient may experience (up to max of 12) shorter than anticipated pacing intervals.

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

1. 31 Jul 2003 Recall initiated FDA recalls Z-0052-04
2. 6 Oct 2006 Recall initiated FDA recalls Z-0298-2007
3. 6 Oct 2006 Recall initiated FDA recalls Z-0296-2007
4. 6 Oct 2006 Recall initiated FDA recalls Z-0297-2007
5. 23 Sep 2011 Recall initiated FDA recalls Z-0430-2012
6. 23 Sep 2011 Recall initiated FDA recalls Z-0429-2012
7. 10 Apr 2017 Listed FDA GUDID 05414734507066
8. 17 Jun 2022 Recall initiated FDA recalls Z-1496-2022
9. 17 Jun 2022 Recall initiated FDA recalls Z-1497-2022
10. 17 Jun 2022 Recall initiated FDA recalls Z-1495-2022

1 earlier event are in the sections above.

Trade name

Assurity™

Generic name

Single-chamber implantable pacemaker, rate-responsive

Model / Ref / Catalog

PM1240

Primary DI / UDI-DI

05414734507066

PMA number

P880086 ↗

FDA product code

NVZ

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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