MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD CARELINK ENCORE; PROGRAMMER, PACEMAKER

Model Number 29901

Device Problems Failure to Power Up (1476); Computer Operating System Problem (2898); Operating System Becomes Nonfunctional (2996)

Patient Problem No Patient Involvement (2645)

Event Date 09/20/2018

Event Type  malfunction  

Manufacturer Narrative

Analysis was unable to confirm the customer comment that the device would not power up, however it did confirm that the device would not boot up.It powered up with a dialog box indicating that the system battery had failed and after initial power-up the programmer would not boot up, it froze at a distorted company logo screen.The battery was replaced to resolve.The software was reconfigured, reloaded and updated and the device then passed all functional, safety and system tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the programmer will not turn on, that it was "completely killed".No error code associated, "crashed and will not reboot." it was further reported via follow-up that following power-up and prior to its use, the user left the room and upon return found the programmer "dead" without an error message.The programmer was returned for service.There was no patient involvement.

Manufacturer Narrative

Failure analysis was performed on the rtc (real time clock) coin cell battery.Visual inspection: no anomalies observed.Benchtop analysis: measured rtc coin cell battery output voltage from wired connector = 0.0 vdc.The insulating cover was removed, and the battery sub-assembly was inspected.There was no observable mechanical damage.All solder joints between contacts and wires were intact and appeared well wetted.Voltage measured directly on the rtc battery contacts surface = 0.0 vdc.Battery depletion confirmed.Conclusion: confirmed complaint of real time clock coin cell battery depletion.The rtc battery did not meet expected longevity.This device was reported as included in the field action noted but returned product investigation found the device did not perform as described in the field action.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CARELINK ENCORE
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• Manufacturer (Section G): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7944220
• MDR Text Key: 123806539
• Report Number: 3004593495-2018-00962
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00643169369030
• UDI-Public: 00643169369030
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 29901
• Device Catalogue Number: 29901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Initial Date Manufacturer Received: 09/20/2018
• Initial Date FDA Received: 10/08/2018
• Supplement Dates Manufacturer Received: 11/14/2018
• Supplement Dates FDA Received: 12/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0407-2019
• Patient Sequence Number: 1