MAUDE Adverse Event Report: MEDTRONIC, INC. SUBQ; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	6996SQ41
Medical Device Problem Codes	Fracture (1260); High impedance (1291)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	07/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of medical devices: 693565 lead implanted: (b)(6) 2017; dtbb1d1 crt-d implanted: (b)(6) 2016.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the right ventricular (rv) lead alerted for a high and undefined superior vena cava (svc) defibrillation imepdance.An svc coil fracture was suspected.The lead was reprogrammed and remains in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was further reported that the right ventricular (rv) lead triggered the alert for high/undefined svc impedance.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SUBQ
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 7698534
• Report Number: 2182208-2018-01309
• Device Sequence Number: 903692
• Product Code: LWS
• UDI-Device Identifier: 00721902183065
• UDI-Public: 00721902183065
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2018

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: 12/28/2010
• Device Model Number: 6996SQ41
• Device Catalogue Number: 6996SQ41
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 08/21/2018; 08/08/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 09/06/2018; 10/02/2018
• 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: 1056T LEAD, 407645 LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR