BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3873254 · Received June 13, 2014

    Report

    Report Number
    3006630150-2014-01340
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE DEVICE HEATS UP WHEN CHARGING AND THE PATIENT HAD A SMALL RASH OR BLISTER AT THE POCKET SITE. THE PHYSICIAN DID NOT SUSPECT THAT THE SYMPTOM WAS CAUSED BY THE IPG OR THE CHARGER. THE PATIENT WAS PRESCRIBED A CREAM AND THE BLISTER WAS GONE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE DEVICE HEATS UP WHEN CHARGING AND THE PATIENT HAD A SMALL RASH OR BLISTER AT THE POCKET SITE. THE PHYSICIAN DID NOT SUSPECT THAT THE SYMPTOM WAS CAUSED BY THE IPG OR THE CHARGER. THE PATIENT WAS PRESCRIBED A CREAM AND THE BLISTER HAS GONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349628 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention