MAUDE Adverse Event Report: PLEXUS MANUFACTURING SDN. BHD; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number 5392

Device Problems Nonstandard Device (1420); Connection Problem (2900); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 10/13/2015

Event Type  malfunction  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

Event Description

It was reported that the external pulse generator had a damaged ventricular node, and that it failed width and sensitivity testing.The generator was returned for service.There was no patient involvement.

Manufacturer Narrative

Product event summary: analysis confirmed the customer comment of a broken ventricular node, the output connector assembly was broken but was unable to confirm the customer comment of failed width and sensitivity.During analysis the device shut down on the tester, no print out.Errors were noted that denoted a pogo pin alignment issue, so the main printed circuit board was realigned and reran the incoming tests after the bench/language fixture testing and then all tests passed.During bench testing it was noted that the device powered up to an error but that it was cleared on language fixture and then powered up on the bench and the device functioned normally.Analysisdid find that the hanger assembly was broken, one case screw was contaminated, the device needs the updated battery shorting bar design and the display and battery wires were pinched but the insulation was not compromised.All found defective parts were replaced and all other identified issues were resolved.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5280190
• MDR Text Key: 33604191
• Report Number: 3004593495-2015-00373
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2015

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: 5392
• Device Catalogue Number: 5392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2015
• Initial Date FDA Received: 12/09/2015
• Supplement Dates Manufacturer Received: Not provided; 11/13/2015
• Supplement Dates FDA Received: 02/09/2016; 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2015
• 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-1356-2015
• Patient Sequence Number: 1