BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SPINAL CORD STIMULATOR

    MDR report key: 1915084 · Received December 1, 2010

    Report

    Report Number
    3007566237-2010-10072
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 18, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MFR EMPLOYEE. TRAINING IS IN PLACE.

    Description of Event or Problem · 1

    RECEIVED INFO REPORTING A DAMAGED CONTACT (NOT ELECTRODE) ON THE LEAD WAS OBSERVED DURING IMPLANT. THE LEAD WAS CONNECTED TO THE EXTENSION AND IMPEDANCE READINGS WERE PERFORMED, INDICATING ABNORMAL FINDINGS. THE LEAD/EXTENSION WAS REMOVED AND REPLACED. IT WAS REPORTED THAT LATER THAT NIGHT, THE PT HAD ALL THE DEVICES EXPLANTED DUE TO POST-OPERATIVE COMPLICATIONS, INCLUDING PROGRESSIVE WEAKNESS. PT REPORTED TO HAVE RECOVERED WITHOUT SEQUELA. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, A F/U REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SPINAL CORD STIMULATOR LGW MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR EXPLANTED:| LEAD: MODEL 3986A, LOT# UNK| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC002659V| EXPLANTED:| IMPLANTED: