BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 1861628 · Received October 8, 2010

    Report

    Report Number
    2649622-2010-10009
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 6, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K896313
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. IT WAS OBSERVED THAT THE VENTRICULAR LEAD IMPEDANCE INCREASED IN (B)(6) 2009.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD HIGH IMPEDANCE, INCREASED THRESHOLDS, A SUSPECTED FRACTURE AND WAS REPROGRAMMED TO UNIPOLAR "FOR THE LAST FEW MONTHS" . IT WAS FURTHER REPORTED THAT THE LEAD WAS CAPPED AND REPLACED. 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. 4058M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention (B)(4) IMPLANTABLE PULSE GENERATOR