MAUDE Adverse Event Report: MEDTRONIC MILACA, INC.; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number 5318

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis: analysis found that after the device was turned on, when the battery was removed the device shuts down automatically.Shutdown current leakage was 74 milliamps.The hook cover was broken and the hook was missing.The printed circuit board assembly, display, ring cover, bail cover and bail were replaced.The device was calibrated.The device then passed functional testing.If information is provided in the future, a supplemental report will be issued.

Event Description

The external pulse generator (epg) was returned to the manufacturer for inspection.It was analyzed and tested out of specification.There was no patient involvement.

• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7562314
• MDR Text Key: 109889217
• Report Number: 2183613-2018-00134
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2018

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: 03/15/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2018
• Initial Date FDA Received: 06/01/2018
• 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