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

Model Number 6495F

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/14/2015

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.The facility was unable to obtain the serial number of the temporary pacing lead and therefore no manufacturing or expiration date were available.(b)(4).

Event Description

Medtronic received information that a piece of this pacing wire broke-off inside the patient during extraction following surgery.Six months post implant of this temporary pacing lead, a piece of the wire was discovered within the patient and was explanted.No other adverse patient effects were reported from this lead.

Manufacturer Narrative

Analysis: the trends for this event type were reviewed.On two separate previous occasions at this same hospital, bipolar pacing wires fractured just before the terminal electrode.Upon removing the wire from the patient, it was noted that the wire was missing the blue polypropylene monofilament coil.No other cases of fracture have been on this product model.Conclusion: the fracture most probably occurred due to fatigue related to flexing with the distal electrode, in combination with, but not limited to, the position of the electrode in the heart tissue, dislodgement, the implant technique and the implant duration.

Event Description

Medtronic received information that a piece of this pacing wire (pli 10) broke-off inside the patient during extraction following surgery.Six months post implant of this temporary pacing lead, a piece of the wire was discovered within the patient and was explanted.No other adverse patient effects were reported from this lead.Medtronic received information that five months post implant of this annuloplasty ring in the mitral position (pli 20), this ring was explanted and replaced with a bioprosthetic heart valve.No specific failure mechanism and no adverse patient effects were reported from this annuloplasty ring.

Manufacturer Narrative

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 STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5413070
• MDR Text Key: 37554613
• Report Number: 2025587-2016-00136
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6495F
• Device Catalogue Number: 6495F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 00066 YR
• Patient Weight: 106