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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI CAPSURE EPICARDIAL LEAD; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
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MPRI CAPSURE EPICARDIAL LEAD; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE Back to Search Results
Model Number 4965-50
Medical Device Problem Code Low impedance (2285)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 12/23/2019
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 a warning was triggered for low pacing impedance on the left ventricular (lv) lead.Undersensing and far field r-wave (ffrw) oversensing were noted on the right atrial (ra) lead.The leads remain in use.No patient complications have been reported as a result of this event.
 
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Brand Name
CAPSURE EPICARDIAL LEAD
Common Device Name
DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR
MDR Report Key10842578
Report Number2649622-2020-22247
Device Sequence Number2903959
Product Code NVN
UDI-Device Identifier00613994501813
UDI-Public00613994501813
Combination Product (Y/N)N
Initial Reporter StateKY
Initial Reporter CountryUS
PMA/510(K) Number
P950024
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 11/16/2020
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 Date09/23/2018
Device Model Number4965-50
Device Catalogue Number4965-50
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/02/2020
Initial Report FDA Received Date11/16/2020
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
DTBA1D4 CRT-D, 5076-52 LEAD, 6947M62 LEAD
Patient Age69 YR
Patient Weight59
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