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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-35
Medical Device Problem Code Impedance Problem (2950)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/19/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 4968-35 lead, implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the patient's lead impedance measurements were varying and that the, "shocking coil was wrapped around the heart in the pericardial space." a particular lead was not specified, but both leads remain 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 Key8245165
Report Number2649622-2019-00764
Device Sequence Number2035945
Product Code LWS
UDI-Device Identifier00613994492388
UDI-Public00613994492388
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 Year2016
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 01/14/2019
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 Date04/07/2017
Device Model Number6937A-35
Device Catalogue Number6937A-35
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/19/2018
Initial Report FDA Received Date01/14/2019
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
D141 ICD
Patient Age10 YR
Patient Weight34
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