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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VIVA S CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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MEDTRONIC PUERTO RICO OPERATIONS CO. VIVA S CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO Back to Search Results
Model Number DTBB1D1
Medical Device Problem Code Premature Discharge of Battery (1057)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/20/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.Analysis of the device revealed normal battery depletion.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that there was high threshold on the left ventricular (lv) lead that caused a short battery life on the cardiac resynchronization therapy defibrillator (crt-d).The lead was capped and replaced and the device was explanted and replaced.No patient complications have been reported as a result of this event.
 
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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 Key10873122
Report Number3004209178-2020-20335
Device Sequence Number3227762
Product Code NIK
UDI-Device Identifier00643169530188
UDI-Public00643169530188
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
P010031
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/19/2020
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 Date06/14/2018
Device Model NumberDTBB1D1
Device Catalogue NumberDTBB1D1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/06/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/20/2020
Initial Report FDA Received Date11/20/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
4479 LEAD, 694758 LEAD, 419478 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age81 YR
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