MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VIVA S; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number	DTBB1D1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2018
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.The returned device had a damaged connector.The returned device indicated a grommet issue, a damaged set screw, and that the set screw was found in the connector bore.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during the implant procedure, the physician connected all the leads to the device.When tugging on the leads to make sure they were connected well in the header, the right ventricular pace/sense pulled out.The setscrew was unscrewed and the lead re-set and tightened down and the lead pulled out again.This was attempted four times with the same result.The device was not used and a new device was implanted.No patient complications have been reported as a result of this event.

• Brand Name: VIVA S
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 7416385
• Report Number: 3004209178-2018-07314
• Device Sequence Number: 1636773
• Product Code: NIK
• UDI-Device Identifier: 00643169929371
• UDI-Public: 00643169929371
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• 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): 04/10/2018

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: Health Professional
• Device Expiration Date: 11/14/2018
• Device Model Number: DTBB1D1
• Device Catalogue Number: DTBB1D1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR