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

Model Number 5392

Device Problems Nonstandard Device (1420); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 06/10/2015

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's connector block was broken.The generator was returned for service.There was no patient involvement.

Manufacturer Narrative

Product event summary: analysis confirmed the customer comment that the connector block was broken and it further noted that the lower case was broken, the battery wire insulation was pinched though the wire insulation was not compromised and that it needed the new battery shorting bar.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: 4972500
• MDR Text Key: 23866143
• Report Number: 3004593495-2015-00204
• 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,health
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Followup
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• 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: 06/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2015
• 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