BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN OTW

    MDR report key: 3993239 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09429
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 31, 2014
    Report Date
    July 23, 2020
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND, HOWEVER THE DISTAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY FRACTURED DUE TO MELTING, AND VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE AND STRETCHING; PARTIAL LEAD IN SEGMENTS RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 6949-65 DEFIB LEAD, IMPLANTED: (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT DIZZY ALL DAY, AND THEN RECEIVED MULTIPLE INAPPROPRIATE SHOCKS AND PRESENTED TO THE EMERGENCY DEPARTMENT. ADDITIONALLY, THERE WAS HIGH IMPEDANCE, OVERSENSING OBSERVED ON ELECTROGRAM (EGM), AND A CONFIRMED FRACTURE. THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT DURING THE EXPLANT PROCEDURE, THE LEFT VENTRICULAR (LV) LEAD WAS DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470227 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419378

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Hospitalization| L| R (B)(4)