BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2190362 · Received July 25, 2011

    Report

    Report Number
    3004209178-2011-05723
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 28, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A LEAD REVISION IN (B)(6) 2011 DUE TO POOR LEAD PLACEMENT. DURING THE SURGERY, THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY VOLTAGE WAS 3.4V. ON (B)(6) 2011, THE PT WENT TO THE CLINIC TO HAVE THE INS TURNED ON AND THE BATTERY VOLTAGE WAS 3.69V. DUE TO THE DISCREPANCY, THE HEALTH CARE PROVIDER REPLACED THE INS AND LEAD. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR : MODEL 7426,| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU084770V| SERIAL #NFW126340H| LEAD: MODEL 3387S, LOT# V024501| IMPLANTED:| LEAD: MODEL 3387S, LOT# V018325| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU084775V| IMPLANTED:| EXPLANTED: