MAUDE Adverse Event Report: MEDTRONIC MILACA, INC. EXTERNAL TEMPORARY PACEMAKER / IMPLANT TOOL MODEL; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number 5318

Device Problem Battery Problem (2885)

Patient Problem No Patient Involvement (2645)

Event Date 12/14/2018

Event Type  malfunction  

Manufacturer Narrative

Product event summary: analysis determined there was an issue noted with the low-voltage back-up battery alarm, automatically shut down at 6.5 volts.It was further indicated that the motor driver board should be replaced, however the device was returned to the customer unrepaired at their request.If information is provided in the future, a supplemental report will be issued.

Event Description

The external pulse generator (epg) was returned for a customer request for inspection and subsequently tested out-of-specification during manufacturer's analysis.There was no patient involvement.

• Brand Name: EXTERNAL TEMPORARY PACEMAKER / IMPLANT TOOL MODEL
• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): MEDTRONIC MILACA, INC.; 900 sixth avenue ne; milaca MN 56353 3728
• Manufacturer (Section G): MEDTRONIC MILACA, INC.; 900 sixth avenue ne; milaca MN 56353 3728
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9285722
• MDR Text Key: 179311446
• Report Number: 2183613-2019-00179
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971474
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/06/2019

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: 5318
• Device Catalogue Number: 5318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 11/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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