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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI TRANSVENE CS/SVC; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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MPRI TRANSVENE CS/SVC; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number 6937A-52
Medical Device Problem Code High impedance (1291)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/27/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Concomitant medical products: ddbb1d1 icd, implanted on (b)(6) 2014.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that there was a high svc (superior vena cava) coil impedance alert triggered for the patient¿s defibrillation lead.The 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
Common Device Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key8453683
Report Number2649622-2019-05014
Device Sequence Number13501060
Product Code LWS
UDI-Device Identifier00613994492401
UDI-Public00613994492401
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
P980050
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 03/26/2019
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 Date11/14/2014
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 02/27/2019
Initial Report FDA Received Date03/26/2019
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
7122 LEAD, 507652 LEAD
Patient Age49 YR
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