MAUDE Adverse Event Report: MEDTRONIC, INC. DEFIB EPI PATCH; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	6721S-50
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the superior vena cava (svc) coil of the patient's epicardial lead triggered an alert for low impedance.The svc coil was programmed off and the lead will continue to be monitored on a daily basis.The lead remains in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated the impedance of the superior vena cava defibrillation coil was below the expected lower range.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DEFIB EPI PATCH
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 8460669
• Report Number: 2182208-2019-00603
• Device Sequence Number: 2926880
• Product Code: LWS
• UDI-Device Identifier: 00681490148818
• UDI-Public: 00681490148818
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P900061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2019

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: 11/13/2020
• Device Model Number: 6721S-50
• Device Catalogue Number: 6721S-50
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 04/12/2019
• 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: 4968-25 LEAD, DDBB1D1 ICD, 6721S-50 LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 MO