BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 1991817 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02564
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015/S012
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    PRODUCT EVENT SUMMARY : THE FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED WITH NO ANOMALIES FOUND. VISUAL ANALYSIS NOTED APPARENT EXPLANT DAMAGE AND THE LEAD WAS STRETCHED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT WHEN THE LEAD HAD DISLODGED PREVIOUSLY, IT ALSO HAD HIGH THRESHOLD AND DID NOT CAPTURE.

    Description of Event or Problem · 1

    IT WAS ALSO NOTED THAT THE LEAD WAS LATER EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD DISLODGED AND THE CAPTURE THRESHOLDS HAD INCREASED SHORTLY AFTER IMPLANT. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 4194 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD