MAUDE Adverse Event Report: MEDTRONIC, INC. DUAL CHAMBER TEMPORARY PACEMAKER; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number 5392

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

Product analysis : analysis confirmed customer comment of code 200 errors.Reset printed circuit board (pcb) with firmware update.Output connector assembly is broken.Upper case is broken.Lower case is broken.Display wires are pinched, wire insulation is exposed.Three case screws are contaminated.All found defective parts were replaced and all other identified issues were resolved.Passed all final functional tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that an error code occurred on the external pulse generator (epg).The epg was returned for repair.No patient complications have been reported as a result of this event.It was further reported that the epg subsequently tested out of specification during manufacturer's analysis.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: DUAL CHAMBER TEMPORARY PACEMAKER
• 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: 9391936
• MDR Text Key: 168456930
• Report Number: 2182208-2019-02150
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

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: Other
• Device Model Number: 5392
• Device Catalogue Number: 5392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 11/29/2019
• Supplement Dates Manufacturer Received: 12/02/2019
• Supplement Dates FDA Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2015
• 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