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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-65
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: 6935m62 lead, implanted: (b)(6) 2014.Product id: 5076-52 lead, implanted: (b)(6) 2014.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the patient's system was removed due to 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
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key8921432
Report Number2649622-2019-15002
Device Sequence Number11362111
Product Code LWS
UDI-Device Identifier00643169535992
UDI-Public00643169535992
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
P980050
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/22/2019
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 Date09/17/2020
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 07/31/2019
Initial Report FDA Received Date08/22/2019
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
DTMA1QQ ICD, 439888 LEAD, 5019 ADAPTOR
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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