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

Model Number 5392

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 07/06/2015

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: the device failed incoming functional testing.The main printed circuit board (pcb) was realigned and the functional testing was rerun but it failed again.The main pcb was swapped out and when functional testing was again rerun the device passed.It was noted that the main pcb was out of specification in an electrical manner.It was further noted that the keypad had a soft lock/unlock button.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

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.Further analysis was performed on the main board.Visual inspection revealed no anomalies.Bench analysis found that the board failed on a functional tester on the atrial channel for output noise.However additional analysis at the bench did not confirm the failure.Conclusion: the failure seen at the test console could not be confirmed.

• 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: 5122747
• MDR Text Key: 27622872
• Report Number: 3004593495-2015-00262
• 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: Followup
• Report Date: 08/03/2015

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: 07/08/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2014
• 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