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

Model Number 5392

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

Patient Problem No Patient Involvement (2645)

Event Date 08/12/2015

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.Product problem: analysis confirmed the customer comment that the generator's connector block was broken and further noted that the device failed its incoming functional testing due to the main printed circuit board (pcb) being misaligned.The pcb was realigned and restested and then the initial failures passed.All found defective parts were replaced and all other identified issues were resolved.(b)(4).

Event Description

It was reported that the external pulse generator's connector block was broken.The generator was returned for service.There was no patient involvement.

• 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: 5133438
• MDR Text Key: 28066480
• Report Number: 3004593495-2015-00217
• 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
• Report Date: 08/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2015
• 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: 08/14/2015
• Date Manufacturer Received: 08/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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