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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 Consequences Or Impact To Patient (2199)
Date of Event 06/01/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: e2dr01aa ipg, implant date:(b)(6) 2004, product id: 4968-25 , product type: lead, implant date:(b)(6) 2004.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that right ventricular (rv) leads exhibited elevated thresholds.The leads were subsequently capped and replaced.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 Key10739123
Report Number2649622-2020-20700
Device Sequence Number1086664
Product Code DTB
UDI-Device Identifier00681490124300
UDI-Public00681490124300
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P120017
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2000
Device Explanted Year2009
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
4965-35 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age22 YR
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