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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI TRANSVENE CS/SVC LEAD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
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MPRI TRANSVENE CS/SVC LEAD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) Back to Search Results
Model Number 6937A-65
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 07/02/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical product: 5019 adaptor, implanted: (b)(6) 2021.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that cardiac resynchronization therapy defibrillator (crt-d) system was explanted approximately six weeks after implant due to an infection.No further patient complications have been reported as a result of this event.
 
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Brand Name
TRANSVENE CS/SVC LEAD
Common Device Name
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key12211484
Report Number2649622-2021-14747
Device Sequence Number16894550
Product Code LWS
UDI-Device Identifier00643169535992
UDI-Public00643169535992
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
P980050
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/22/2021
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? No
Operator of Device Lay User/Patient
Device Expiration Date02/02/2023
Device Model Number6937A-65
Device Catalogue Number6937A-65
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/02/2021
Initial Report FDA Received Date07/22/2021
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
DTPB2QQ CRT-D, 5076-52 LEAD, 479888 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age36 YR
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