MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 6495F

Device Problems Break (1069); Unraveled Material (1664)

Patient Problem No Information (3190)

Event Date 09/14/2018

Event Type  Injury  

Manufacturer Narrative

Conclusion: medtronic has received the product and the analysis is in progress.A supplemental report will be submitted upon completion of the analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that this pacemaker dependent patient had temporary pacing leads implanted following a heart valve implant.On day 2 post operative the temporary pacing lead exhibited loss of capture.It was believed that the lead had "broken" and "unraveled".The patient required adrenaline be administered.No additional adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that as a result of the loss of capture, the patients heart rate reduced to 50bpm which subsequently caused a reciprocal drop in his blood pressure.In accordance with this deterioration, the patient was then commenced on an adrenaline infusion and 5 days later discharged with no further complications.Added patient weight to field.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic received additional information that upon return of these temporary pacing wires to medtronic, it was noted that they are not manufactured by medtronic.No further information is required.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MEDTRONIC
• 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: 7948194
• MDR Text Key: 123115043
• Report Number: 2025587-2018-02683
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K161249
• 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,Followup
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2019
• Device Model Number: 6495F
• Device Catalogue Number: 6495F
• Device Lot Number: CAB157206F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2018
• Initial Date FDA Received: 10/09/2018
• Supplement Dates Manufacturer Received: 10/22/2018; 01/21/2019
• Supplement Dates FDA Received: 10/23/2018; 01/22/2019
• Date Device Manufactured: 09/08/2017
• 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: 89 YR
• Patient Weight: 69