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

Model Number	5019
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2017
Type of Reportable Event	Malfunction
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 oversensing due to non-physiologic signals/sensing integrity counter.Analysis of the device memory indicated the impedance of the right ventricular pacing lead was beyond the expected upper range.Analysis of the device memory indicated pacing capture threshold in the right ventricle was elevated.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the patient required placement of an additional array due to high defibrillation testing where three shocks were needed to convert the rhythm.The array was connected via the adaptor to the device.Defibrillation testing was performed with success and all the measurements were found to be within normal range.Approximately two or three days later, the right ventricular lead displayed high thresholds, there was a jump in impedance and the impedance was high.Testing revealed the high values were repeatedly confirmed.Following, the patient was admitted to the operating room for a lead revision; however, at that time the measurements were found to be normal.It was also reported there was a possibility there was an interaction with the adaptor.The cardiologist and surgeon decided to follow the patient and the lead revision was not performed.The device and lead remain in use and no patient complications have been reported as a result of this event.

• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 7254993
• Report Number: 2182208-2018-00119
• Device Sequence Number: 19136071
• Product Code: LWS
• UDI-Device Identifier: 00613994220288
• UDI-Public: 00613994220288
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/08/2018

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: 03/24/2018
• Device Model Number: 5019
• Device Catalogue Number: 5019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 43 YR