MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VISIA AF MRI S VR SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	DVFC3D1
Medical Device Problem Codes	Signal Artifact/Noise (1036); Mechanical Problem (1384); Over-Sensing (1438)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that approximately two weeks post an implantable cardioverter defibrillator (icd) changeout the right ventricular (rv) lead had triggered a lead integrity alert (lia) with noise that was able to be reproduced with isometrics and by 'tapping the can'.It was noted that prior to the icd changeout there had not been any noise seen on the device or lead and it was assumed that there was a loose set screw.A revision procedure was conducted, and the pocket was opened.The cathode was completely thru the header, and a tug test showed no issue.Cables were connected and the lead was manipulated with noise being present, so the physician decided to implant a new rv lead and df4 connector icd on the off chance that it was a header issue.The device was extracted and replaced and the lead was partially removed, capped and replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VISIA AF MRI S VR SURESCAN
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 9477322
• Report Number: 3004209178-2019-23923
• Device Sequence Number: 16869605
• Product Code: LWS
• UDI-Device Identifier: 00643169837829
• UDI-Public: 00643169837829
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2020

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: 03/28/2020
• Device Model Number: DVFC3D1
• Device Catalogue Number: DVFC3D1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/03/2020
• 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; Required Intervention
• Patient Age: 64 YR