BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

    MDR report key: 2953060 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00882
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    June 6, 2012
    Report Date
    November 29, 2012
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCORRECT SUSPECT MEDICAL DEVICE MODEL 5086MRI/SERIAL (B)(4) WAS INADVERTENTLY REPORTED FOR THIS COMPLAINT UNDER MANUFACTURING REPORT NUMBER 2649622-2013-00882 AND AS A RESULT THIS REPORT IS BEING REDACTED. THE AVAILABLE INFORMATION REASONABLY SUGGESTS THAT A MEDTRONIC PRODUCT WAS NEITHER A CAUSE NOR A CONTRIBUTING FACTOR IN A DEATH OR SERIOUS INJURY AND THE AVAILABLE INFORMATION REASONABLY SUGGESTS THAT THE DEVICE WAS ABLE TO PERFORM ITS ESSENTIAL FUNCTION. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: (B)(4) IMPLANTABLE PACING LEAD 2012 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THREE WEEKS AFTER IMPLANT THE DEVICE/WIRES "HAD TO BE REPLACED BECAUSE THE LEADS BECAME DISCONNECTED" AND THAT "THE WIRES PULLED OUT". THE PATIENT ALSO STATED THEY HAD TO BE ADMITTED TO THE HOSPITAL FOUR TIMES IN THE FOUR MONTHS WITH CHEST PAINS. ACCORDING TO THE PATIENT THEY COULDN'T FIND ANYTHING WRONG WITH DEVICE AT THE EMERGENCY ROOM, BUT AFTERWARDS WHEN WALKING THE PATIENT "ALMOST FELL ON HIS FACE", AND THEIR HEART RATE WAS FOUND TO ONLY BE AT 60. THE PATIENT STATED THEY HAD HIS RATE "STACKED AT 60" AND DOESN'T KNOW WHY. THE DEVICE AND LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FURTHER INFORMATION FROM THE CLINIC INDICATES THE RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED AND WAS REVISED. THE DEVICE AND RIGHT ATRIAL (RA) LEAD ARE FUNCTIONING NORMALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THREE WEEKS AFTER IMPLANT THE DEVICE/WIRES "HAD TO BE REPLACED BECAUSE, THE LEADS BECAME DISCONNECTED" AND THAT "THE WIRES PULLED OUT". THE PATIENT ALSO STATED THEY HAD TO BE ADMITTED TO THE HOSPITAL FOUR TIMES IN THE FOUR MONTHS WITH CHEST PAINS. ACCORDING TO THE PATIENT THEY COULDN'T FIND ANYTHING WRONG WITH DEVICE AT THE EMERGENCY ROOM, BUT AFTERWARDS WHEN WALKING THE PATIENT "ALMOST FELL ON HIS FACE", AND THEIR HEART RATE WAS FOUND TO ONLY BE AT 60. THE PATIENT STATED THEY HAD HIS RATE "STACKED AT 60" AND DOESN'T KNOW WHY. THE DEVICE AND LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56078 DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI45

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)