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

Model Number 5392

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

Analysis was able to confirm the customer comment , the liquid crystal display (lcd) was cracked.The device failed incoming functional tests, the lcd was bleeding.It was also identified that the hanger assembly was broken , the encoder assembly and knobs were contaminated.The lower case was broken, dented and contaminated.All found defective parts were replaced and all other identified issues were resolved.The epg then passed all final functional tests.

Event Description

It was reported that the bottom screen of the external pulse generator (epg) was cracked.There was no patient involvement.

• 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: 12533668
• MDR Text Key: 273366646
• Report Number: 2182208-2021-03815
• Device Sequence Number: 1
• Product Code: DTE
• UDI-Device Identifier: 00763000162443
• UDI-Public: 00763000162443
• 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: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• 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: 09/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2018
• 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