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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 6996SQ58
Medical Device Problem Code Signal Artifact/Noise (1036)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/08/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 4968-60, lead, implanted: (b)(6) 2015.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the right ventricular (rv) lead had oversensing of noise.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 Key10092783
Report Number2649622-2020-10055
Device Sequence Number2626049
Product Code LWS
UDI-Device Identifier00613994568021
UDI-Public00613994568021
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
P920015
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 05/27/2020
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 Date04/16/2019
Device Model Number6996SQ58
Device Catalogue Number6996SQ58
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/11/2020
Initial Report FDA Received Date05/27/2020
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
6721L-50 LEAD, CD1411-36C ICD
Patient Age72 YR
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