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

Model Number 5388X

Device Problem Use of Device Problem (1670)

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

Event Date 09/14/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the analysis could not confirm the customer comment of the external pulse generator (epg) did not work.The incoming test on automated test system ts4 passed.It was also determined at analysis that the hanger, ring and ring covers are missing.The bail attachment cover is missing, and the lower case is cracked.The patient output connectors are polluted.The device was scrapped.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the external pulse generator (epg) did not work.The product was returned for service, and subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.

• Brand Name: DUAL CHAMBER TEMPORARY PACEMAKER
• Type of Device: PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
• 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: 10926534
• MDR Text Key: 219000986
• Report Number: 2183613-2020-00130
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P820003
• 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: 12/01/2020

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: 5388X
• Device Catalogue Number: 5388X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2003
• 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