BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPULSE

    MDR report key: 1921488 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05774
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S030
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. EVALUATION SUMMARY (B)(4) UPON ANALYSIS IT WAS REPORTED THAT THERE WERE NO ANOMALIES FOUND. (B)(4) UPON ANALYSIS IT WAS REPORTED THAT THE OUTER INSULATION HAD BREACHED DEPRESSION WAS BREACHED CUT, TORN, AND THERE WAS A COSMETIC DEPRESSION. ALSO NOTED THAT THE DISTAL CONDUCTOR WAS STRETCHED, THE PROXIMAL CONDUCTOR HAD BLOOD/BODY FLUID (NON-OBSTRUCTING), AND THE TIP ELECTRODE INSULATION WAS PULLED APART FROM APPARENT OVERSTRESS. THE DISTAL SEGMENT OF THE LEAD WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS "TWISTING" OF THE VENTRICULAR LEAD AND THE PATIENT WAS REPORTED TO HAVE TWIDDLER SYNDROME. THE LEAD AND DEVICE WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENPULSE IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. E2SR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R