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

Model Number 5392

Device Problems Device Displays Incorrect Message (2591); Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 03/21/2017

Event Type  malfunction  

Manufacturer Narrative

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.The device is no longer included as part of the field action.Product event summary: manufacturer¿s analysis confirmed the customer comment that the device presented with an error; the main printed circuit board (pcb) tested out-of-specification in an electrical manner.It was also noted that the red display wire was pinched with the wire exposed.All found defective parts were replaced and all other identified issues were resolved.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the external pulse generator (epg) presented with an error code.The epg has been returned to service.There was no patient involvement.It was further reported that the returned external pulse generator (epg) tested out of specification during manufacturer¿s analysis.

Manufacturer Narrative

Failure analysis was performed on the main board.Visual inspection: no anomalies.Benchtop analysis: powered on with error 805.Red dye penetrant was used prior to mechanically removing the package to elucidate any existing cracks within the solder balls.The samples were analyzed using standard operating procedures with the following instruments: hirox kh-8700 digital microscope.Results: red dye was found at a solder joint.Red dye was found on the pwb (printed wiring board) side of the hybrid at two solder joint locations.Conclusion: the occurrences of red dye found on the solder joint and on the pwb side of the hybrid indicate that pre-existing cracks may have been present at those interfaces.The logs were reviewed.Multiple 805 and 303 errors.Conclusion: confirmed customer complaint of 805 errors.Fractured solder joint between die stack and the pcba (printed circuit board assembly).If information is provided in the future, a supplemental report will be issued.

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): 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: 6781240
• MDR Text Key: 82592265
• Report Number: 3004593495-2017-00428
• 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,Followup
• Report Date: 10/03/2018

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: 5392
• Device Catalogue Number: 5392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2017
• Initial Date FDA Received: 08/09/2017
• Supplement Dates Manufacturer Received: 08/01/2018; 08/08/2018
• Supplement Dates FDA Received: 08/06/2018; 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2014
• 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