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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI SCREW-IN LEAD; ELECTRODE, PACEMAKER, PERMANENT
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MPRI SCREW-IN LEAD; ELECTRODE, PACEMAKER, PERMANENT Back to Search Results
Model Number 5071-25
Medical Device Problem Code High Capture Threshold (3266)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 12/02/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that right ventricular (rv) epicardial lead exhibited high thresholds.It was also reported that the abdominal, single chamber implantable pulse generator (ipg) exhibited premature battery depletion post two and a half years, due to high thresholds of rv lead.Both the rv lead and the abdominal ipg were inactivated and replaced with a leadless ipg.No patient complications have been reported as a result of this event.
 
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Brand Name
SCREW-IN LEAD
Common Device Name
ELECTRODE, PACEMAKER, PERMANENT
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key11037724
Report Number2649622-2020-24949
Device Sequence Number16470833
Product Code DTB
UDI-Device Identifier00681490124300
UDI-Public00681490124300
Combination Product (Y/N)N
Initial Reporter StateHI
Initial Reporter CountryUS
PMA/510(K) Number
P120017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2020
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) 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date02/26/2019
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 12/02/2020
Initial Report FDA Received Date12/18/2020
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
W1SR01 IPG
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age70 YR
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