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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 Codes Low impedance (2285); Impedance Problem (2950)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 02/15/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the pacing impedance on the epicardial lead increased shortly after implant.It was also noted that the defibri llation impedance was decreasing and was noted to have become low.The leads remain 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 Key11365370
Report Number2649622-2021-03513
Device Sequence Number11583941
Product Code LWS
UDI-Device Identifier00643169541184
UDI-Public00643169541184
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
P920015
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/23/2021
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 02/15/2021
Initial Report FDA Received Date02/23/2021
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
4968-25 LEAD, DVPB3D1 ICD
Patient Age4 YR
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