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

Model Number 5392

Device Problems Nonstandard Device (1420); Device Inoperable (1663)

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

Event Date 11/25/2015

Event Type  Injury  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: analysis was unable to confirm the customer comment that the device stopped working.It was noted that it failed an incoming test step for ventricular sensitivity however when the main printed circuit board was realigned and the unit retested then all passed.Analysis also noted that both output connectors were broken, the display wire insulation was pinched but not compromised and that the unit needed the updated battery shorting bar design.All found defective parts were replaced and all other identified issues were resolved.(b)(4).

Event Description

It was reported that while pacing a patient the external pulse generator stopped working.The batteries were changed out but this did not resolve the situation.The generator was changed out and returned for service.No patient complications have been reported as a result of this event.

• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): PLEXUS MANUFACTURING; bayan lepas free indus 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: 5425458
• MDR Text Key: 37909661
• Report Number: 3004593495-2016-00076
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• PMA/PMN Number: K150246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: Yes
• 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: 12/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2015
• 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
• Patient Outcome(s): Required Intervention