BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 2201788 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11198
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 5, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K902002
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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): THE DISTAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND. THE DEFIBRILLATION CONDUCTOR WAS DISTORTED AND THERE WAS BLOOD/BODY FLUID (NOT OBSTRUCTED) ON SEVERAL CONDUCTORS. THE INNER TUBING WAS KINKED/BUCKLED, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, AND THERE WAS A WHITE SUBSTANCE ON THE EXPOSED DEFIBRILLATION COIL. THERE WAS BLOOD IN/ON THE HELIX MECHANISM SLEEVE HEAD AND ON THE HELIX MECHANISM ITSELF AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND. THERE WAS BLOOD/BODY FLUID (NOT OBSTRUCTED) ON THE DISTAL CONDUCTOR AND A COSMETIC DEPRESSION ON THE OUTER INSULATION. (B)(4): INITIALLY, THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED WITH NO ANOMALIES FOUND. SUBSEQUENTLY, THE DEVICE WAS RETURNED AND ANALYZED AND ANALYSIS REVEALED THE DEVICE MET 83% OF EXPECTED LONGEVITY. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL.

    Description of Event or Problem · 1

    DURING A DEVICE REPLACEMENT DUE TO NORMAL BATTERY DEPLETION, IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD HAD HIGH IMPEDANCE, HIGH THRESHOLD AND NO CAPTURE. THE LEAD WAS TESTED WITH THE ANALYZER AND PRODUCED ACCEPTABLE VALUES. THE LEAD WAS EXPLANTED. THE RIGHT VENTRICULAR [RV] LEAD HAD HIGH IMPEDANCE, SUBSTANTIAL NOISE ON THE ELECTROGRAM, AND AN APPARENT LEAD FRACTURE. DURING THE LEAD EXTRACTION PROCEDURE THE FOLLOWING WEEK, THE OLD RV LEAD WAS EXPLANTED. A NEW RV LEAD WAS PLACED, BUT HAD TO BE REPOSITIONED DUE TO T-WAVE OVERSENSING. AFTER GOOD FIXATION, T-WAVE OVERSENSING WAS TEMPORARILY ABSENT, HOWEVER AFTER SUTURING THE LEADS WITHIN THE POCKET, T-WAVE OVERSENSING RETURNED. THE RV LEAD WAS REPOSITIONED AGAIN TO A MORE APICAL POSITION AND THERE WAS NO T- WAVE OVERSENSING. THE LEAD IS STILL IN USE. SUBSEQUENT TO THE LEAD REVISION, THE DEVICE WAS RETURNED TO THE MANUFACTURER AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW-IN IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5071 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD