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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 Pacing Problem (1439)
Health Effect - Clinical Code Dyspnea (1816)
Date of Event 09/12/2019
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 the patient was experiencing shortness of breath and they "feel worse" with their new cardiac resynchronization therapy defibrillator (crt-d).It was determined that the patient's heart rate was below the crt-d's programmed lower rate.The crt-d was reprogrammed and remains in use.No further 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 Key9150529
Report Number3004209178-2019-18894
Device Sequence Number14249535
Product Code NIK
UDI-Device Identifier00643169720329
UDI-Public00643169720329
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
P010031
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 10/03/2019
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 Date12/28/2020
Device Model NumberDTBB1D1
Device Catalogue NumberDTBB1D1
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/12/2019
Initial Report FDA Received Date10/03/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age75 YR
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