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

Model Number 6491F

Device Problem Detachment Of Device Component (1104)

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

Event Date 09/14/2016

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis.Without the receipt of the product, no definitive conclusion can be made regarding the clinical observation.Additional information, including the physician who initially reported this incident to a medtronic employee, has been requested, but no information has been received.If new information is received, or if the device is received for analysis, a supplemental report will be submitted.

Event Description

Medtronic received information that approximately two weeks post implant of this temporary pacing wire, the tip remained in the patient's myocardium after the device was explanted.No additional intervention was reported and no adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that the device remaining in the patient will be removed at a future time during a cardiac surgery procedure for a different purpose; no specific intervention to remove this device was reported as having occurred.Physician name added in section e.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis: two products were returned for analysis.The event is confirmed on one product, which distal electrode tip is missing, the conductor wire is broken at the distal edge of the insulation.The second product is confirmed not damaged and electrically functional.The observed blue monofilament tail is too short, to indicate that the monofilament coil provided as a fixation feature while the lead was implanted.A review of the device history record of the batch associated with this event had been performed to verify any potential of manufacturing issue.The trends for this event type were reviewed.No issue for corrective action in manufacturing is identified.Conclusion the fracture observed at the distal edge of the conductor wire on the returned product was most likely due to fatigue, related to the flexing of the wire next to the electrode tip edge.As indicated in the instruction for use, other items may have affected the performance of the lead like, but not limited to: location of implant, patient tissue condition, loss of implant location, the implant technique, etc¿ combined with the implant time (two weeks).The instructions for use indicates that the model is intended for temporary atrial and ventricular pacing and sensing for contemplated implant duration of 7 days or less.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.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: 6001397
• MDR Text Key: 56543701
• Report Number: 2025587-2016-01573
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K012454
• 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,Followup
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2019
• Device Model Number: 6491F
• Device Catalogue Number: 6491F
• Device Lot Number: AAA208205F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2016
• 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