BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEUROSTIMULATOR

    MDR report key: 3020944 · Received March 26, 2013

    Report

    Report Number
    3007566237-2013-00889
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37083-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3877-45, LOT # 0206426279, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37083-40, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3877-45, LOT# 0206426279. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT INAPPROPRIATE STIMULATION WAS DUE TO THE EXTENSION, BECAUSE SINCE IT WAS REPLACED, THE STIMULATION RESUMED TO NORMAL STATE. THE ONLY PART OF THE SYSTEM THAT MIGRATED WAS THE CONNECTOR BETWEEN LEAD AND EXTENSION. IT WAS VISUALLY REMARKED THAT THE ISOLATION PLASTIC CAP OVER CONNECTOR WASN'T PROPERLY FIXED BUT THERE WAS NO REASON TO EXPLAIN WHY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED "INAPPROPRIATE STIMULATION." IT WAS ADDITIONALLY REPORTED THAT "LEAD MIGRATION" HAD OCCURRED. THE PATIENT'S PHYSICIAN WAS NOTED TO HAVE "REPLACED THE EXTENSION." THE PATIENT'S STATUS AT THE TIME OF REPORT WAS NOTED AS "ALIVE - NO INJURY/NO ADVERSE EVENT." IT WAS ADDITIONALLY NOTED THAT THERE "WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT." A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE LEAD COMPONENT OF THE IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM REMAINED IMPLANTED AND ¿IN SERVICE.¿ THE PATIENT WAS REPORTED AS DOING ¿VERY WELL.¿ IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123456 UNKNOWN NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention