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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI MYOCARDIAL LEAD; ELECTRODE, PACEMAKER, PERMANENT
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MPRI MYOCARDIAL LEAD; ELECTRODE, PACEMAKER, PERMANENT Back to Search Results
Model Number 5071-25
Medical Device Problem Code Low impedance (2285)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/17/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Continuation of concomitant products: dtba1d4 crt-d, implanted (b)(6) 2016.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the left ventricular (lv) lead exhibited low impedance.Follow up yielded no information.The lv lead remains in use.No patient complications have been reported as a result of this event.
 
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Brand Name
MYOCARDIAL LEAD
Common Device Name
ELECTRODE, PACEMAKER, PERMANENT
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key7514611
Report Number2649622-2018-08186
Device Sequence Number16769488
Product Code DTB
UDI-Device Identifier00681490124300
UDI-Public00681490124300
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
P120017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/15/2018
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 Date10/02/2016
Device Model Number5071-25
Device Catalogue Number5071-25
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/24/2018
Initial Report FDA Received Date05/15/2018
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
5076-52 LEAD, 6947M62 LEAD
Patient Age52 YR
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