BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION®

    MDR report key: 2071795 · Received April 28, 2011

    Report

    Report Number
    3006630150-2011-00614
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT WAS REPORTEDLY DOING WELL AFTER THE PROCEDURE. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL# SC-1110-02 (B)(4)DESCRIPTION: IPG KIT (WITHOUT PULL-THROUGH TUNNELER).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION INDICATED THE PATIENT WILL NOT UNDERGO A IPG REVISION. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE IPG FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS HAVING DIFFICULTIES CHARGING HIS IPGS. THE PATIENT IS CURRENTLY IMPLANTED WITH TWO IPGS AND HAS RECENTLY UNDERGONE THREE MRIS. THE BSN REPRESENTATIVE ATTEMPTED TO TROUBLESHOOT THE PATIENT, HOWEVER WAS UNSUCCESSFUL. THE PHYSICIAN RECOMMENDED THE PATIENT TO UNDERGO A REVISION PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS HAVING DIFFICULTIES CHARGING HIS IPGS. THE PATIENT IS CURRENTLY IMPLANTED WITH TWO IPGS AND HAS RECENTLY UNDERGONE THREE MRIS. THE BSN REPRESENTATIVE ATTEMPTED TO TROUBLESHOOT THE PATIENT, HOWEVER WAS UNSUCCESSFUL. THE PHYSICIAN RECOMMENDED THE PATIENT TO UNDERGO A REVISION PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS HAVING DIFFICULTIES CHARGING HIS IPGS. THE PATIENT IS CURRENTLY IMPLANTED WITH TWO IPGS AND HAS RECENTLY UNDERGONE THREE MRIS. THE BSN REPRESENTATIVE ATTEMPTED TO TROUBLESHOOT THE PATIENT, HOWEVER, WAS UNSUCCESSFUL. THE PHYSICIAN RECOMMENDED THE PATIENT UNDERGO A REVISION PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR