BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA SR

    MDR report key: 1071927 · Received July 10, 2008

    Report

    Report Number
    2647346-2008-00348
    Event Type
    Injury
    Date Received
    July 10, 2008
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: NO ANOMALIES FOUND; FULL LEAD RETURNED IN SEGMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WAS REMOVED AFTER COMPLICATIONS AT ANOTHER HOSPITAL. FOLLOW UP WAS ATTEMPTED, BUT NO FUTHER INFORMATION HAS BEEN PROVIDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA SR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. ADSR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 4968 IMPLANTABLE PACING LEAD