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

Model Number	6721S-50
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260); Over-Sensing (1438); Decreased Sensitivity (2534); Impedance Problem (2950)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: d314drg icd, implanted: (b)(6) 2012 and pb1018 valve, implanted: (b)(6) 2008.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) coil of the high voltage left ventricular (lv) epicardial lead triggered a lead integrity alert (lia) for an elevated number of short v-v intervals, varying rv coil impedance, and noise on high rate non-sustained episodes.It was further reported that the r-waves were diminished and the rv coil was fractured.The lead was reprogrammed and later capped and replaced.No patient complications have been reported as a result of this event.

• 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: 8587898
• Report Number: 2182208-2019-00850
• Device Sequence Number: 1809629
• Product Code: LWS
• UDI-Device Identifier: 00681490148818
• UDI-Public: 00681490148818
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P900061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2019

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: 11/28/2006
• Device Model Number: 6721S-50
• Device Catalogue Number: 6721S-50
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 05/07/2019
• 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: 4968-35 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 28 YR
• Patient Weight: 57