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

Model Number	6996SQ58
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Discharge (2225)
Date of Event	05/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: dtma1d1 crt-d, implanted: (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that had an infection with a pocket of pus noted at the device site.Cultures were taken and antibiotic treatment was necessary.The device and leads were explanted and will be replaced in the future.During the extraction, the left ventricular (lv) lead broke off and remains in the patient.No further 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: 10144643
• Report Number: 2182208-2020-01085
• Device Sequence Number: 11506741
• Product Code: LWS
• UDI-Device Identifier: 00721902183072
• UDI-Public: 00721902183072
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/28/2005
• 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: 05/19/2020
• Initial Report FDA Received Date: 06/11/2020
• 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: 5076-52 LEAD, 419378 LEAD, 694765 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 47