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

Model Number 6494

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 08/02/2018

Event Type  malfunction  

Manufacturer Narrative

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 that 2 days post implant of these temporary pacing wires, half way up, the wires snapped and broke off.No adverse patient effects were reported.

Manufacturer Narrative

Medtronic received further detailed patient/event information during investigation, requiring the creation of separate events.This medwatch contains specific information for one of the patients.The other two medwatches submitted are: 2025587-2018-02650 and 2025587-2018-02651.

Event Description

Medtronic received information that two days post implant of this temporary pacing lead, the lead broke in half.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: 7821141
• MDR Text Key: 118402258
• Report Number: 9611350-2018-00003
• 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: Physician
• Type of Report: Initial,Followup
• 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?: Yes
• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2018
• Initial Date FDA Received: 08/27/2018
• Supplement Dates Manufacturer Received: 09/04/2018
• Supplement Dates 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
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR