BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1842711 · Received September 23, 2010

    Report

    Report Number
    2649622-2010-09042
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    September 2, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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.

    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) NO ANOMALIES FOUND; FULL LEAD IN SEGMENTS WAS RETURNED FOR ANALYSIS. BLOOD/BODY FLUID WAS OBSERVED ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED). THE INNER INSULATION WAS KINKED/BUCKLED. THE INNER INSULATION WAS KINKED/BUCKLED, THERE WERE COSMETIC DEPRESSIONS AND A WHITE SUBSTANCE WAS OBSERVED. THE LEAD WAS STRETCHED AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4) NO ANOMALIES FOUND; DISTAL SEGMENT WAS RETURNED FOR ANALYSIS. ALL THE CONDUCTORS WERE STRETCHED. BLOOD/BODY FLUID WAS OBSERVED ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED). THE OUTER INSULATION WAS BREACHED/CUT AND HAD COSMETIC CUTS AND DEPRESSIONS. THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS OVERSENSING ON THE ATRIAL AND VENTRICULAR LEADS. BOTH LEADS WERE EXPLANTED AND REPLACED. IT WAS FURTHER REPORTED THAT THERE WAS AN INSULATION TEAR ON THE VENTRICULAR LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS ASKU DTB MEDTRONIC PUERTO RICO, INC. 5092 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention SD303 IMPLANTABLE PULSE GENERATOR| SD303 IMPLANTABLE PULSE GENERATOR