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

Model Number	6721L-50
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 6721m-50 lead, implanted: (b)(6) 2016; 4968-60 lead, implanted: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) battery depleted prematurely.The device was explanted and replaced.It was also reported that the two epicardial defibrillation patches dislodged as they appeared to have migrated away from the heart towards the diaphragm.The patches were capped.The surgeon was unable to retrieve the dislodged patches as one had migrated to a trough around the diaphragm and one had scarred over below and behind the heart.A subcutaneous coil was implanted and successfully converted the patient during defibrillation testing.The coil remains in use.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: 7940104
• Report Number: 2182208-2018-01808
• Device Sequence Number: 19262954
• Product Code: LWS
• UDI-Device Identifier: 00681490148733
• UDI-Public: 00681490148733
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P900061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/05/2018

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: 07/11/2018
• Device Model Number: 6721L-50
• Device Catalogue Number: 6721L-50
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 10/05/2018
• 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: 511212 LEAD (X2), 511211 LEAD (X2), 6721L-50 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 125