BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1694251 · Received May 18, 2010

    Report

    Report Number
    3006630150-2010-00838
    Event Type
    Injury
    Date Received
    May 18, 2010
    Date of Event
    December 1, 2009
    Report Date
    March 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS FEELING A SHOCKING SENSATION IN THE BACK OF HER HEAD. THE PATIENT HAS AN OCCIPITAL IMPLANT. THE PATIENT REPORTED FEELING A HEATING SENSATION AT HER IPG SITE WHEN SHE IS CHARGING. THE PATIENT'S DATABASE ANALYSIS DID NOT SHOW ANY SIGNS OF PREMATURE BATTERY DEPLETION. THE PATIENT MET WITH THE BSN FIELD CLINICAL ENGINEER (FCE) WHO DID NOT OBSERVE ANY IMPEDANCE ISSUES WITH THE LEADS NOR ANY ANOMALIES IN THE IPG CHARGING HISTORY. THE BSN FCE CONFIRMED THAT THE PATIENT'S SECOND LEAD WAS CAUSING THE PATIENT SCALP PAIN BY APPLYING LOW ENERGY PULSES. THE BSN FCE CONFIRMED THAT THERE WERE NO ELECTRICAL CONDUCTIVITY ISSUES. THE PATIENT WAS REFERRED TO A PHYSICIAN FOR AN OCCIPITAL REVISION CONSULTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2138-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention MODEL # SC-2138-70| MODEL # SC-1110| IMPLANTABLE PULSE GENERATOR (IPG)| (B) (4)| (B) (4)| (B) (4)| LINEAR LEAD, 70 CM WITH PRE-LOADED 0.012" STYLET