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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-52
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 09/03/2021
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 an infection occurred and the implantable cardioverter defibrillator (icd) was explanted.The status of the leads is unknown.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 Key12519818
Report Number2649622-2021-19381
Device Sequence Number19859271
Product Code LWS
UDI-Device Identifier00643169536029
UDI-Public00643169536029
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
P980050
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/23/2021
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 Date10/17/2020
Device Model Number6937A-52
Device Catalogue Number6937A-52
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/10/2021
Initial Report FDA Received Date09/23/2021
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
4968-35 LEADS X2, DDMB1D1 ICD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age18 YR
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