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

Model Number 5392

Device Problems Nonstandard Device (1420); Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 10/12/2015

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 the device failed initial incoming testing, it crashed the system and no print-out.The testing was rerun with the same outcome.The main printed circuit board was realigned and the incoming test was rerun again this time all passed except one generated error which was expected.Analysis further noted that the battery wires were pinched and not compromised but were replaced as a preventive, the output connector assembly was broken, the device log initially showed no errors when received the first dump, then showed 720 and 810 after initial testing after the initial system crash.All found defective parts were replaced and all other identified issues were resolved.(b)(4).

Event Description

The external pulse generator was returned with no information 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: 5283145
• MDR Text Key: 33625820
• Report Number: 3004593495-2015-00378
• 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: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• 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: 10/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2014
• 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