BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2965056 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02105
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    December 17, 2012
    Report Date
    March 5, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES. HOWEVER, THE LEAD HELIX WAS DISTORTED DUE TO BEING PULLED/STRETCHED/OVERSTRESS. VISUAL ANALYSIS NOTED THAT THE LEAD WAS RETURNED WITH THE HELIX STRETCHED AND A LEAD REMOVAL WIRE STUCK IN THE LEAD. THE STRETCHED HELIX IS LIKELY DUE TO ATTEMPTED IMPLANT DAMAGE. DUE TO THE HELIX BEING STRETCHED AND THE PRESENCE OF A LEAD REMOVAL WIRE, THE HELIX EXTENSION/RETRACTION AND LENGTH TESTING COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT, THE PHYSICIAN WAS REPOSITIONING THE RIGHT VENTRICULAR (RV) LEAD DUE TO HIGH THRESHOLDS BUT THE HELIX WOULD NOT RETRACT. IT WAS NOTED THAT THE HELIX WAS TESTED PRIOR TO IMPLANT. THE PHYSICIAN PLACED A LOCKING STYLET ON THE LEAD AND EXTRACTED IT. THE LEAD WAS NOT IMPLANTED AND ANOTHER LEAD WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED ASA RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67794 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR