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

Model Number 5318

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 06/12/2019

Event Type  malfunction  

Manufacturer Narrative

Product analysis: at analysis it was noted that the device would automatically shut down as soon as the battery was removed.It was additionally noted that the customer did not accept the quote for the repair costs and requested that the device be returned to them.If information is provided in the future, a supplemental report will be issued.

Event Description

The external pulse generator was returned for evaluation 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, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8797728
• MDR Text Key: 151280069
• Report Number: 2182208-2019-01280
• 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: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• 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: 06/12/2019
• Date Manufacturer Received: 07/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2010
• 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