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

Model Number	DVAB1D4
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2018
Type of Reportable Event	Malfunction
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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during implant, the wrench was not able to set into the set screw in the header of the implantable cardioverter defibrillator (icd).It was noted that the set screw appeared to have shifted so it was not seated into the correct spot, therefore the wrench was not able to engage and screw down the set screw.The icd was removed and a new icd was implanted to complete the operation.No patient complications have been reported as a result of this event.

• Brand Name: VISIA AF XT VR ICD
• 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: 7915365
• Report Number: 3004209178-2018-21702
• Device Sequence Number: 19046830
• Product Code: LWS
• UDI-Device Identifier: 00643169929760
• UDI-Public: 00643169929760
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• 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,Followup
• Report Date (Section B): 10/11/2018

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: 04/14/2019
• Device Model Number: DVAB1D4
• Device Catalogue Number: DVAB1D4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR