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

Model Number 5392

Device Problems Mechanical Problem (1384); Nonstandard Device (1420)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

This report is based solely on device analysis.No information to suggest a device related adverse event or product problem was received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: it was noted on analysis that the device would not run on initial functional testing, the main printed circuit board (pcb) was realigned and then the device ran but failed the serial number read test.The main pcb was realigned again and the pins on the tester were cleaned as well and when rerun it all passed.It was additionally noted that the device failed final testing with two errors however the incoming testing was rerun, one error regenerated which was expected, the tester was cleared and the device powered up on the bench normally.The main pcb was being replaced as a preventive measure.It was further noted that the battery wires were pinched however the wires were not compromised and the lower case was being replaced as a preventive, the keypad was separated from the lens and the updated battery shorting bar was needed.All found defective parts were replaced and all other identified issues were resolved.(b)(4).

Event Description

The external pulse generator was returned in accordance with instructions affiliated with the current corrective field action and subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.

Manufacturer Narrative

Further analysis was performed on the main board and lower case.Visual inspection revealed no anomalies.Bench analysis found that the board passed all console testing.It was noted that the lower case had a breach in the insulation on the black battery wire.Additional analysis of the device log contained no errors.The error seen during servicing of the device is consistent with a pinched black wire.Conclusion: the device had a pinched black battery wire.

• 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: 5280013
• MDR Text Key: 33556507
• Report Number: 3004593495-2015-00375
• 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
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/14/2015

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: 10/05/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2015
• Initial Date FDA Received: 12/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2014
• 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