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

Model Number	6996SQ41
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 693558 lead, implanted: (b)(6) 2012, 1688tc lead implanted; (b)(6) 2004; 419388 lead, implanted: 18-mar-2004.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that there was an alert superior vena cava (svc) lead for high/undefined pacing impedance.The lead remains in use.No patient complications have been reported as a result of this event.

• Brand Name: SUBCUTANEOUS, UNIPOLAR LEAD
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 13059765
• Report Number: 2182208-2021-05049
• Device Sequence Number: 14440843
• Product Code: LWS
• UDI-Device Identifier: 00721902183065
• UDI-Public: 00721902183065
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/14/2005
• Device Model Number: 6996SQ41
• Device Catalogue Number: 6996SQ41
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 12/22/2021
• Date Device Manufactured: 04/24/2003
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DTBB1D1 CRT-D
• Patient Age: 63 YR
• Patient Sex: Male