BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2161923 · Received July 14, 2011

    Report

    Report Number
    3006630150-2011-01040
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT UNDERWENT A POCKET REVISION PROCEDURE. THE PHYSICIAN EXPLANTED THE IPG AND IMPLANTED THE PATIENT WITH A NEW IPG. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE. DEVICE ANALYSIS CONFIRMED THE COMPLAINT. THE DEVICE READ LOW IMPEDANCES WITH NO LOAD ATTACHED. IT WAS DETERMINED THAT THE ANALOG IC HAD DAMAGE WHICH ALLOWED CURRENT TO LEAK THROUGH THE CASE NODE AND DEPOSIT EXCESSIVE CHARGE ON OUTPUT CAPACITORS 1-3, 6-8, 10-13 AND 15-16. THE DAMAGE TO THE ANALOG IC IS A RESULT OF THE PATIENT UNDERGOING AN MRI PROCEDURE. OUR LITERATURE CLEARLY STATES MRI IS NOT TO BE PERFORMED ON A PATIENT THAT IS CURRENTLY IMPLANTED WITH A PRECISION SCS SYSTEM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING A BURING SENSATION AT THE IPG SITE, SEVERE SHOCKING, AND WARMTH WHILE CHARGING. THE IPG DATABASE ANALYSIS CONFIRMED NO ABNORMALITIES WERE PRESENT. HOWEVER, THE PHYSICIAN HAS RECOMMENDED AN IPG REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING A BURING SENSATION AT THE IPG SITE, SEVERE SHOCKING, AND WARMTH WHILE CHARGING. THE IPG DATABASE ANALYSIS CONFIRMED NO ABNORMALITIES WERE PRESENT. HOWEVER, THE PHYSICIAN HAS RECOMMENDED AN IPG REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention