BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 7879318 · Received September 14, 2018

    Report

    Report Number
    3006630150-2018-60907
    Event Type
    Injury
    Date Received
    September 14, 2018
    Date of Event
    August 13, 2018
    Report Date
    November 16, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5001613/5006061, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN DID NOT SUSPECT IT WAS DEVICE RELATED. THE PATIENT SWEAT A LOT AND THOUGHT TO BE RELATED TO THE PATIENTS SWEATING INTO THE WOUNDS. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE DEVICES WAS FOUND TO BE SATISFACTORY.

    Additional Manufacturer Narrative · 1

    SC-1160, (SN (B)(4)). DEVICE EVALUATION INDICATED THAT THE PATIENT HAPPENED TO SWEAT A LOT. THE DEVICE WAS EVALUATED FOR A POSSIBLE MALFUNCTION AGAINST THE REPORTED EVENT. RESIDUAL GAS ANALYSIS VERIFIED NO LOSS OF ELECTRIC CURRENT INTO THE SURROUNDING TISSUE BECAUSE OF FAULTY INSULATION. REVIEW OF THE STERILIZATION RECORD DID NOT FIND ANY ANOMALIES OR DEVIATIONS THAT POTENTIALLY RELATE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A SUSPECTED INFECTION BUT NO INFECTION FOUND. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A SUSPECTED INFECTION BUT NO INFECTION FOUND. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A SUSPECTED INFECTION BUT NO INFECTION FOUND. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720129 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 335776 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention