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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 Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/01/2002
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 the right atrial (ra) lead exhibited a lead failure.The device was reprogrammed to vvi pacing and the lead was subsequently inactivated and replaced.No further 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 Key10739136
Report Number2649622-2020-20699
Device Sequence Number19104196
Product Code DTB
UDI-Device Identifier00681490124300
UDI-Public00681490124300
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P120017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2000
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/27/2020
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 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 10/12/2020
Initial Report FDA Received Date10/27/2020
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
KDR721 IPG, 4965-35 LEAD, 5071-25 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age4 YR
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