MAUDE Adverse Event Report: MEDTRONIC ?SUBCUTANEOUS UNIPOLAR LEAD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 6996SQ

Device Problems Failure to Interrogate (1332); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Device Dislodged or Dislocated (2923); Protective Measures Problem (3015)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

It was reported that the patient with the implantable cardioverter defibrillator (icd) received multiple shocks, at this time there is not enough information to confirm if these where appropriate or not.Also, the device was unable to be interrogated since it was found to be at end of life (eol).It was also noted that this non boston scientific sq lead had dislodged and coiled up into the pocket.A lead revision was performed and defibrillation threshold (dft) test on this lead was not successful for several attempts.A new non boston scientific sq lead was implanted successfully.The device was explanted due to normal battery depletion (nbd).It is expected to receive this device for analysis.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ?SUBCUTANEOUS UNIPOLAR LEAD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17488963
• MDR Text Key: 320688083
• Report Number: MW5121662
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 6996SQ
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1