BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1844627 · Received September 23, 2010

    Report

    Report Number
    3006630150-2010-01604
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S LEADS SHOWED HIGH IMPEDANCES. THE PHYSICIAN FEELS ONE OF THE LEADS MIGHT BE NICKED. ALTHOUGH THE PHYSICIAN RECOMMENDED A LEAD REVISION, THE PATIENT DECLINED SURGERY AS HE IS RECEIVING ADEQUATE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW SC-8216-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention MODEL # SC-8216-70| SERIAL # (B)(4)| ARTISAN 2X8 PADDLE LEAD (LIM), 70 CM