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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. VIVA QUAD XT CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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MEDTRONIC PUERTO RICO OPERATIONS CO. VIVA QUAD XT CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO Back to Search Results
Model Number DTBA1QQ
Medical Device Problem Code Pacing Problem (1439)
Health Effect - Clinical Code Bradycardia (1751)
Date of Event 03/25/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Concomitant medical products: zy52 lead, implanted (b)(6) 1991.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the device was allowing the patient's heart rate to drop into the 30s, which was below the programmed lower rate.The cardiac resynchronization therapy defibrillator (crt-d) remains in use.No further patient complications have been reported as a result of this event.
 
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Brand Name
VIVA QUAD XT 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 Key11685276
Report Number3004209178-2021-06231
Device Sequence Number16877780
Product Code NIK
UDI-Device Identifier00643169720138
UDI-Public00643169720138
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
P010031
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 04/19/2021
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 Date08/14/2019
Device Model NumberDTBA1QQ
Device Catalogue NumberDTBA1QQ
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/25/2021
Initial Report FDA Received Date04/19/2021
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
6935M62 LEAD, 439888 LEAD
Patient Age70 YR
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