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

Model Number	DTBB1D1
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the device was interrogated and the battery voltage was below the level indicated for implant.The battery voltage was still below the level indicated for implant after the device was at room temperature for over a week.The device was not used.There was no patient involvement.

• Brand Name: VIVA¿ S CRT-D
• 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: 9721251
• Report Number: 3004209178-2020-03554
• Device Sequence Number: 361982
• Product Code: NIK
• UDI-Device Identifier: 00643169720329
• UDI-Public: 00643169720329
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P010031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

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: Other
• Device Expiration Date: 02/28/2020
• Device Model Number: DTBB1D1
• Device Catalogue Number: DTBB1D1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1