BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3870051 · Received June 12, 2014

    Report

    Report Number
    6000153-2014-00118
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    NEURO - VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37702, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3550-29, LOT# N311900, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE PATIENT WAS HAVING A REVISION OF THE CATHETER FOR THEIR PUMP SYSTEM, THE HEALTH CARE PROVIDER (HCP) ACCIDENTALLY CUT THE LEAD FOR THEIR STIMULATOR. IT WAS REPORTED THAT THE LEAD WAS REPLACED. INFORMATION OMITTED PERTAINING TO EVENT (B)(4) ¿ CATHETER REPLACED. THESE EVENTS ARE ONLY RELATED IN THE FACT THAT THE LEAD WAS CUT DURING THE CATHETER REPLACEMENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT IS STILL RECOVERING AND THE STIMULATOR HAS NOT BEEN TURNED BACK ON OR HAD IT SCHEDULED TO BE TURNED ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347763 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW NEURO - VILLALBA 3777-75

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention