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

Model Number 5388

Device Problem Calibration Problem (2890)

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

Event Date 08/27/2021

Event Type  malfunction  

Manufacturer Narrative

Product analysis: it was determined on analysis that the external pulse generator (epg) tested out of specification during incoming tests due to parameters being out of tolerance.The atrial output encoder was defective and parameters could not be set correctly.The epg passed all tests using the test encoder.It was also noted that the bail cover, bails and ring cover and ring were missing.The case was broken at the back of the atrial connector.The instrument was decommissioned.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the external pulse generator (epg) which was returned for service subsequently tested out of specification during manufacturer's assessment.There was no patient involvement.

• Brand Name: DUAL CHAMBER TEMPORARY PACEMAKER
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 14511591
• MDR Text Key: 292720022
• Report Number: 2183613-2022-00063
• 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: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 5388
• Device Catalogue Number: 5388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Date Manufacturer Received: 05/02/2022
• 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