3203

• FDA PMA P110042 decided 28 Sep 2012 Active
• FDA GUDID UDI-DI 00802526542220 listed 24 Sep 2014 Listed

• 2 recalls, same reason

  • Ongoing Z-2441-2023 FDA Class II ·initiated 11 Jul 2023
  • Ongoing Z-2442-2023 FDA Class II ·initiated 11 Jul 2023

  There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.

• 2 recalls, same reason

  • Ongoing Z-0151-2023 FDA Class II ·initiated 30 Sep 2022 ·on shared PMA P110042
  • Ongoing Z-0152-2023 FDA Class II ·initiated 30 Sep 2022 ·on shared PMA P110042

  There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.

• • Terminated Z-0474-2019 FDA Class II ·initiated 1 Nov 2018

  Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions.

• 3 recalls, same reason

  • Terminated Z-3038-2017 FDA Class II ·initiated 29 Jun 2017
  • Terminated Z-3037-2017 FDA Class II ·initiated 29 Jun 2017
  • Terminated Z-3039-2017 FDA Class II ·initiated 29 Jun 2017

  The device can deliver an atypical amount of energy due to memory corruption inside the device.

• • Terminated Z-1178-2017 FDA Class II ·initiated 12 Jan 2017

  There is a potential for radio frequency (RF) interference to alter wireless communication from a programmer, which in rare instances may cause an S-ICD to perform an unintended command. This behavior can only occur during an active, in-clinic interrogation/programming session with the Model 3200 S-ICD programmer. There is no risk of this behavior occurring when the LATITUDE Patient Management System communicates with an S-ICD in an ambulatory setting.

• • Terminated Z-0232-2016 FDA Class II ·initiated 17 Sep 2015

  Devices shipped to US in dual-channel rather than US approved single-channel RF Telemetry communication mode. While this does not impact therapy delivery of device; this can impact likelihood of successfully establishing telemetry during first scan of device when using a single-channel programmer. Telemetry can be established with additional scans; once established no further difficulty is expecte

• • Terminated Z-0965-2013 FDA Class II ·initiated 1 Mar 2013

  An internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. Should this occur, the defibrillator would not be able to deliver therapy or communicate with the Q-TECH Model 2020 programmer, and would be unable to emit tones or otherwise respond to magnet application.

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

1. 17 Sep 2015 Recall initiated FDA recalls Z-0232-2016
2. 12 Jan 2017 Recall initiated FDA recalls Z-1178-2017
3. 29 Jun 2017 Recall initiated FDA recalls Z-3038-2017
4. 29 Jun 2017 Recall initiated FDA recalls Z-3037-2017
5. 29 Jun 2017 Recall initiated FDA recalls Z-3039-2017
6. 1 Nov 2018 Recall initiated FDA recalls Z-0474-2019
7. 30 Sep 2022 Recall initiated FDA recalls Z-0151-2023
8. 30 Sep 2022 Recall initiated FDA recalls Z-0152-2023
9. 11 Jul 2023 Recall initiated FDA recalls Z-2441-2023
10. 11 Jul 2023 Recall initiated FDA recalls Z-2442-2023

3 earlier events are in the sections above.

Generic name

Cardiac pulse generator programmer

Model / reference

3203

Primary DI / UDI-DI

00802526542220

PMA number

P110042 ↗

FDA product code

LWS

GMDN term

Cardiac pulse generator programmer

Device class

Class III

GUDID distribution status

In Commercial Distribution

Category: Cardiac pulse generator programmer

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