BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 2003712 · Received February 23, 2011

    Report

    Report Number
    3006630150-2011-00227
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A RETURNED PRODUCT ANALYSIS INDICATED THAT THE COMPLAINT OF THE INABILITY TO FULLY CHARGE THE IPG WAS NOT CONFIRMED. THE IPG EXHIBITS NORMAL CHARGING AND DISCHARGING CHARACTERISTICS WHEN CHARGED WITH RECOMMENDED OPTIMAL ALIGNMENT. NO COMPLAINTS ABOUT THE FUNCTIONALITY OF THE LEADS WERE REPORTED. DAMAGE TO THE LEADS IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE. A REVIEW OF THE STERILIZATION RECORDS OF THE EXPLANTED DEVICES FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS HAVING CHARGING ISSUES. THE PATIENT ALSO REPORTED THAT SHE MET WITH AN ACCIDENT AND SINCE THAN HER IPG SITE IS TENDER AND PAINFUL TO TOUCH. THE PHYSICIAN EXPLANTED THE IPG AND THE LEADS. THE PHYSICIAN COMMENTED THAT " THE SITE DOES NOT LOOK INFECTED AND IT HAS NOTHING TO DO WITH THE DEVICE." THE PATIENT WAS PLACED ON IV ANTIBIOTICS. THE PATIENT WAS REPORTEDLY DOING WELL AFTER THE EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS HAVING CHARGING ISSUES. THE PATIENT ALSO REPORTED THAT SHE MET WITH AN ACCIDENT AND SINCE THEN HER IPG SITE IS TENDER AND PAINFUL TO TOUCH. THE PHYSICIAN EXPLANTED THE IPG AND THE LEADS. THE PHYSICIAN COMMENTED THAT "THE SITE DOES NOT LOOK INFECTED AND IT HAS NOTHING TO DO WITH THE DEVICE." THE PATIENT WAS PLACED ON IV ANTIBIOTICS. THE PATIENT WAS REPORTEDLY DOING WELL AFTER THE EXPLANT PROCEDURE.

    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 62 YR Hospitalization| R (B)(4)| ST LINEAR LEAD, 70CM WITH PRE-LOADED 0.014" STYLET| MODEL #: SC-2218-70, (B)(4)