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

Model Number 5392

Device Problems Break (1069); Difficult to Insert (1316); Blocked Connection (2888)

Patient Problem No Patient Involvement (2645)

Event Date 09/02/2016

Event Type  malfunction  

Manufacturer Narrative

Product event summary: manufacturer¿s analysis confirmed the customer comment that a pin was stuck in the ventricular output connector of the device.It was also noted that the hanger assembly was broken, and both display wires were pinched without compromise to the insulation.All found defective parts were replaced and all other identified issues were resolved.

Event Description

It was reported that the external pulse generator had a broken pin in the output connector; the ventricular lead was unable to insert.The external pulse generator has been returned for repair.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): PLEXUS MANUFACTURING SDN. BHD; bayan lepas free industrial zo; bayan lepas 11900 ; MY 11900
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6161693
• MDR Text Key: 62233721
• Report Number: 3004593495-2016-00517
• Device Sequence Number: 1
• Product Code: DTE
• UDI-Device Identifier: 00643169508767
• UDI-Public: 00643169508767
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2016
• 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: 09/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1