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

Model Number 5392

Device Problems Nonstandard Device (1420); Moisture or Humidity Problem (2986); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 11/17/2015

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: analysis confirmed the customer comment that the device had been saturated in water, there was contamination throughout.It was noted that the lower case bottom boss was broken, there was contamination in the battery compartment and drawer, the atrial output connector was broken, the display was contaminated and had pinched wires that were exposed, the display frame was discolored and contaminated, the display grommets were contaminated, all the display frame screws were contaminated, the main printed circuit board was contaminated, one case screw was contaminated and one was missing, the main seal was installed incorrectly and was replaced as a preventive, the main printed circuit board had one screw loose and all its screws were contaminated, the decretive plugs were contaminated and damaged (tool marks/holes) and the hanger o-ring was missing.All found defective parts were replaced and all other identified issues were resolved.(b)(4).

Event Description

The external pulse generator was returned as it was found saturated with water 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 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: 5425846
• MDR Text Key: 38469235
• Report Number: 3004593495-2016-00067
• 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
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• 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: 11/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2015
• 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