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

Model Number 6494

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/30/2018

Event Type  malfunction  

Manufacturer Narrative

Medwatch: 9611350-2018-00003 was previously submitted containing general information regarding product from the same hospital.Medtronic received further detailed patient/event information during investigation, requiring the creation of a separate event.This medwatch contains specific information for one of the patients.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that five days post implant of this temporary pacing lead, as the patient was moving from one room to another, the pacing lead broke.No adverse patient effects were reported. .

• Brand Name: UNIPOLAR 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: 7935952
• MDR Text Key: 122808425
• Report Number: 2025587-2018-02651
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K140972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2018

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: 6494
• Device Catalogue Number: 6494
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2018
• Initial Date FDA Received: 10/04/2018
• 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