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

Model Number 5392

Device Problems Corroded (1131); Low Battery (2584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2016

Event Type  malfunction  

Event Description

It was reported that the external pulse generator indicated battery depletion despite having new batteries and that the batteries appeared to have been corroded by the device.The generator has not been returned for service.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: analysis confirmed the customer complaint of "battery depletion despite new batteries and batteries appear to have been corroded by the device", and noted that the battery contacts were corroded.At incoming testing the device passed all tests.The device was cleaned, checked and calibrated and then passed all tests on the automated test system.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.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 further reported that the product was returned to service.

• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): PLEXUS MANUFACTURING SND. BHD; bayan lepas free industr zone; bayan lepas ; MY
• Manufacturer (Section G): PLEXUS MANUFACTURING SND. BHD; bayan lepas free industr zone; bayan lepas ; MY
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5859679
• MDR Text Key: 51773850
• Report Number: 3004593495-2016-00325
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K150246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• 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: 08/31/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2013
• 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