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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI TRANSVENE CS/SVC LEAD; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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MPRI TRANSVENE CS/SVC LEAD; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number 6937A-58
Medical Device Problem Code High impedance (1291)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/24/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 6947, lead, implanted: (b)(6) 2010.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that an alert was triggered due to high superior vena cava (svc) coil impedance.The transvene svc lead remains in use.No patient complications have been reported as a result of this event.
 
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Brand Name
TRANSVENE CS/SVC LEAD
Common Device Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key9613345
Report Number2649622-2020-01643
Device Sequence Number16290039
Product Code LWS
UDI-Device Identifier00643169535985
UDI-Public00643169535985
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
P980050
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/21/2020
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 Date09/01/2017
Device Model Number6937A-58
Device Catalogue Number6937A-58
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/27/2019
Initial Report FDA Received Date01/21/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age49 YR
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