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

Model Number	6721L-50
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Shock from Patient Lead(s) (3162)
Date of Event	02/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: cd3257 icd, implanted: (b)(6) 2013.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported by the patient's husband that the patient's right ventricular (rv) lead fractured and caused multiple inappropriate shocks.The patient went into atrial fibrillation (af) and turned blue and was revived with an automated external defibrillator.The husband claimed that the lead was reprogrammed off but not replaced.No further 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.

• 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: 7703993
• Report Number: 2182208-2018-01321
• Device Sequence Number: 2580229
• Product Code: LWS
• UDI-Device Identifier: 00681490148733
• UDI-Public: 00681490148733
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P900061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 11/28/2010
• Device Model Number: 6721L-50
• Device Catalogue Number: 6721L-50
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 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: 496835 LEAD, 496860 LEAD, 511211 LEAD,
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 60 YR