MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 6495

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event and explant date are year valid only.Relevant history: the device manufacturer of the prosthetic aortic valve is unknown.Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from a patient's spouse that an unknown duration post implant and subsequent removal of this temporary pacing lead, magnetic resonance imaging (mri) revealed that a portion of the pacing lead remained in the patient's body.The duration that the temporary pacing lead was implanted prior to removal was not reported.No interventions were performed to remove the portion of the lead remaining in the body, and no adverse patient effects related to the lead were reported.

• Brand Name: BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9547714
• MDR Text Key: 181981674
• Report Number: 2025587-2020-00033
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K012460
• 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: 01/03/2020

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: 6495
• Device Catalogue Number: 6495
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2019
• Initial Date FDA Received: 01/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 73 YR