BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2132944 · Received June 17, 2011

    Report

    Report Number
    3006630150-2011-00920
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION REVEALED THAT THE IPG WAS SET AT A SLANT IN THE POCKET WHICH MAY HAVE CAUSED THE CHARGING DIFFICULTY. THE PHYSICIAN REPLACED THE IPG. THE COMPLAINT OF DIFFICULTY CHARGING DUE TO THE IPG BEING AT A POOR CHARGING ANGLE/SLANT WAS CONFIRMED. CHARGE PROFILE REVEALED VARIOUS TIMES OF ERRATIC COUPLING/POOR ALIGNMENT OF THE CHARGER TO THE IPG. THE CHARGE CURRENT SOMETIMES REACHED ITS MAXIMUM, AND INDICATES GOOD ALIGNMENT, BUT THIS OPTIMAL ALIGNMENT WAS NOT CONSISTENT. BATTERY PROFILE REVEALED A MAXIMUM DEPLETION RATE OF 12MV PER DAY, WHICH IS WITHIN THE EXPECTED RANGE. DEVICE EXHIBITS NORMAL CHARGING AND DISCHARGING CHARACTERISTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTIES OBTAINING A FULL CHARGE ON HER IPG. AN X-RAY WAS TAKEN THAT CONFIRMED THE IPG HAD MIGRATED. A POCKET REVISION HAS BEEN RECOMMENDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTIES OBTAINING A FULL CHARGE ON HER IPG. AN X-RAY WAS TAKEN THAT CONFIRMED THE IPG HAD MIGRATED. A POCKET REVISION HAS BEEN RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention