BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3091756 · Received May 3, 2013

    Report

    Report Number
    3007566237-2013-01515
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    November 23, 2012
    Report Date
    April 17, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 39565-30, LOT# 0206298383, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS PREVIOUSLY REPORTED THAT THE PATIENT WAS "SATISFIED WITH NEUROMODULATION AND WAS RECEIVING EFFECTIVE THERAPY". THIS INFORMATION PERTAINS TO MANUFACTURER REPORT # 3007566237-2013-01526. THE PATIENT OUTCOME FOR THIS EVENT IS CURRENTLY UNKNOWN, BUT FOLLOW UP IS BEING CONDUCTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT FELT BETTER BUT STILL HAD PAIN IN THE ANTERIOR THIGH. IT WAS STATED THAT THE PATIENT WOULD "FOLLOW UP IN REEDUCATION" AND THAT THE PATIENT WAS SATISFIED WITH NEUROMODULATION AND WAS RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT AFTER THE EVACUATION SURGERY OF THE HEMATOMA THE PATIENT FELT BETTER, BUT STILL HAD PAIN IN THE ANTERIOR THIGH. THE PATIENT HAD FOLLOW UP RE-EDUCATION. IT WAS STATED THAT THE PATIENT WAS "SATISFIED WITH NEUROMODULATION" AND WAS RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD BEEN EXPLANTED DUE TO SPINAL HEMATOMA WITH COMPRESSION OF MARROW. PATIENT STATUS AT THE TIME OF THIS REPORT WAS STATED AS ALIVE - WITH INJURY. SHE HAD RECOVERED FUNCTIONAL WALKING WITH TECHNICAL ASSISTANCE, AND USED WHEELCHAIR TO GO OUTSIDE. HOSPITALIZATION, MEDICAL, AND SURGICAL INTERVENTIONS WERE REQUIRED AS A RESULT OF THE EVENT. PATIENT SYMPTOMS/COMPLICATIONS WERE LOSS OF REFLEXES IN LOWER EXTREMITIES, PAIN, AND PARALYSIS. THERE WAS ALSO PARESTHESIA IN THE LOWER PART OF THE BODY UP TO THE NAVEL, WITH A LOSS OF SENSITIVITY. IT WAS ALSO STATED THAT "IT WAS ASSOCIATED WITH A LOSS OF MOTOR FUNCTION OF HER 2 LOWER LIMBS." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED NO FURTHER TROUBLESHOOTING WAS DONE AND THE PATIENT HAD RECOVERED FUNCTIONAL WALKING WITH TECHNICAL ASSISTANCE. IT WAS STATED THE PATIENT¿S LEAD WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195104 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Hospitalization| R| S