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

Model Number	6721S-50
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 right ventricular defibrillation coil was beyond the expected upper range.Concomitant medical products.Model: 511211, competitor lead; implanted: (b)(6) 2013.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient's spouse phoned into patient/technical service due to hearing an audible alert from the patients implantable cardioverter defibrillator (icd).Later that same day the patient presented to the emergency department.A remote transmission was sent.Information received on the remote transmission was reviewed by qualified personnel.It was determined that the patient's right ventricular (rv) defibrillation coil patch and superior vena cava (svc) defibrillation coil patch had triggered alerts for high impedance.Which could be suggestive of a lead fracture.Follow-up was conducted.It was verified that no reprogramming has been completed at this time.The leads remain 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: 7462853
• Report Number: 2182208-2018-00771
• Device Sequence Number: 1067715
• Product Code: LWS
• UDI-Device Identifier: 00681490148818
• UDI-Public: 00681490148818
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P900061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/14/2014
• 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: 04/04/2018
• Initial Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR