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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI SUBCUTANEOUS, UNIPOLAR LEAD; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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MPRI SUBCUTANEOUS, UNIPOLAR LEAD; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number 6996SQ41
Medical Device Problem Code High impedance (1291)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 03/29/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Concomitant medical products: dtmb1d4 icd, implanted: (b)(6) 2020.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the lead warning triggered, and the subcutaneous superior vena cava (svc) coil exhibited high/undefined impedances.The lead remains in use.No patient complications have been reported as a result of this event.
 
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Brand Name
SUBCUTANEOUS, UNIPOLAR LEAD
Common Device Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key9995765
Report Number2649622-2020-08254
Device Sequence Number17102999
Product Code LWS
UDI-Device Identifier00643169541184
UDI-Public00643169541184
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
P920015
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/24/2020
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 Date11/14/2023
Device Model Number6996SQ41
Device Catalogue Number6996SQ41
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/29/2020
Initial Report FDA Received Date04/24/2020
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
0292 LEAD, 4135 LEAD, 4592 LEAD
Patient Age46 YR
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