MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION WIRE 6500F TEMP HEARTWIRE; HEART-VALVE, MECHANICAL

Model Number 6500F

Device Problems Pacing Problem (1439); Material Split, Cut or Torn (4008)

Patient Problems Atrial Flutter (1730); Cardiopulmonary Arrest (1765); Torsades-de-Pointes (2107); Ventricular Fibrillation (2130); No Information (3190)

Event Date 09/06/2018

Event Type  Injury  

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 an unknown duration post implant of this temporary pacing lead, the lead was providing "inappropriate" stimulation resulting in "twisting of the peaks".The patient required heart massage and the lead was replaced.The biomedical department tested the generator and confirmed it was functioning as expected.No additional adverse patient effects were reported.

Manufacturer Narrative

Multiple attempts to obtain the implant and explant date of the lead were unsuccessful.The connection between the external generator (confirmed functioning as expected by the hospital biomedical department), and extension cable (when used) including the potential degradation and/or additional connection, or lead dislodgement combined with the medical condition and anatomy of the patient, may be foreseen as a potential root cause for the clinical observation.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic received additional information that after the procedure, the patient demonstrated an episode of torsades de pointes (tdp).It worsened into ventricular fibrillation which required cardiopulmonary resuscitation (cpr) and an electrical shock.After this, the patient obtained sinus rhythm.The healthcare professional stated the respiratory arrest was related to an appropriate spike of the epicardial electrodes on a t-wave.The patient was reported to have successfully recovered from this incident.The patient was reported to currently have atrial flutter at non-rapid variable conduction.No additional intervention or adverse patient effects were reported.The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, two leads of the same model (6500) were returned intact.Visual inspection of the leads under magnification revealed no immediate visual failure.Kinks and bends were noted on the leads as expected after use.Electrical testing confirmed the resistance, intermittency, and dielectric withstanding voltage of both temporary pacing leads performed within design specifications.Electrical testing showed insulation damage (cut) approximately 18mm proximal to the electrode on the first lead and 25 mm proximal to the electrode on the second lead.Conclusion: the potential root cause for the noted insulation damage is likely related to contact with a sharp point during the procedure.If information is provided in the future, a supplemental report will be issued.

• Brand Name: WIRE 6500F TEMP HEARTWIRE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 8095252
• MDR Text Key: 128062495
• Report Number: 2025587-2018-03158
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• PMA/PMN Number: K171253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2020
• Device Model Number: 6500F
• Device Catalogue Number: 6500F
• Device Lot Number: DAB166306F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Date Manufacturer Received: 06/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention