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

Model Number 5392

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

Patient Problem No Patient Involvement (2645)

Event Date 07/31/2015

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: during analysis reassembly the battery drawer would not open without batteries in it and therefore the lower case was replaced for being out of specification in a mechanical manner.All found defective parts were replaced and all other identified issues were resolved.(b)(4).

Event Description

The external pulse generator was returned as a loaner restock and subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.

• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industr zone; 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: 5120667
• MDR Text Key: 27537831
• Report Number: 3004593495-2015-00295
• 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
• Report Date: 08/14/2015

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: 08/04/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2013
• 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