BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION

    MDR report key: 7351556 · Received March 19, 2018

    Report

    Report Number
    3006630150-2018-01093
    Event Type
    Malfunction
    Date Received
    March 19, 2018
    Date of Event
    January 10, 2018
    Report Date
    March 26, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-2215-50 SERIAL#: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM.

    Additional Manufacturer Narrative · 1

    CORRECTION TO THE INITIAL MDR IN FIELDS SHOULD HAVE BEEN: ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#: SC-2215-50, SERIAL#: (B)(4), DESCRIPTION: LINEAR ST LEAD; 50CM MODEL#: SC-1110-02, SERIAL#: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WILL BE NO IMMEDIATE COURSE OF ACTION AT THIS TIME.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD LOSS OF STIMULATION DUE TO HIGH IMPEDANCES. THE PATIENT WILL UNDERGO A SYSTEM SWAP.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD LOSS OF STIMULATION DUE TO HIGH IMPEDANCES. THE PATIENT WILL UNDERGO A SYSTEM REPLACEMENT. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191328 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR