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

Model Number 5392

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 10/03/2019

Event Type  malfunction  

Manufacturer Narrative

Product event summary: analysis was able to confirm the customer comment that the cable pin was stuck inside the ventricular connector.It was also noted that the display wire was pinched, insulation was not compromised.All found defective parts were replaced and all other identified issues were resolved.The device then passed all functional tests.If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported that the epg was returned for service.

Manufacturer Narrative

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

Event Description

It was reported that the cable was stuck in the ventricular connector on the external pulse generator (epg).The status of the epg is unknown.There was no patient involvement.

• Brand Name: DUAL CHAMBER TEMPORARY PACEMAKER
• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• 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: 9246677
• MDR Text Key: 176341785
• Report Number: 2183613-2019-00175
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K150246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

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: Health Professional
• Device Model Number: 5392
• Device Catalogue Number: 5392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 10/28/2019
• Supplement Dates Manufacturer Received: 11/26/2019
• Supplement Dates FDA Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2014
• 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