MAUDE Adverse Event Report: MEDTRONIC, INC. SUBCUTANEOUS, UNIPOLAR LEAD; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	6996SQ58
Medical Device Problem Codes	Fracture (1260); High impedance (1291); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 507652 lead implanted (b)(6) 2005; ddbb1d1 icd (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient heard alerts from the device and was admitted to the hospital.A check on the device shows alerts from the right ventricular (rv) lead for high impedance on the rv coil, and high impedance on the subcutaneous high voltage superior vena cava (svc) lead.The svc lead also had increased impedance measurements and a fracture was suspected.The svc lead was programmed off and remains in the patient.Defibrillation threshold testing (dft) was successfully performed on the rv coil, and it remains in use.No patient complications have been reported as a result of this event.

• Brand Name: SUBCUTANEOUS, UNIPOLAR LEAD
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 10861186
• Report Number: 2182208-2020-02871
• Device Sequence Number: 19820779
• Product Code: LWS
• UDI-Device Identifier: 00721902183072
• UDI-Public: 00721902183072
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/28/2013
• Device Model Number: 6996SQ58
• Device Catalogue Number: 6996SQ58
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2020
• Initial Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 693565 LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR