BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFY

    MDR report key: 3252893 · Received July 29, 2013

    Report

    Report Number
    6000153-2013-00144
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 2013
    Manufacturer
    NEURO - VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PLACEMENT OF A SURGICAL LEAD NEURODIAGNOSTIC TESTING WAS DONE AND THERE WAS SIGNIFICANT CHANGE IN LATENCY AND AMPLITUDE WITH THE PATIENT¿S READINGS SO THE CASE WAS ABORTED. THE REPORTER STATED THE PATIENT WOKE AND COULD NOT MOVE THEIR SHOULDERS. IT WAS NOTED AN MRI WAS PERFORMED AND THE PATIENT HAD A SPINAL CORD INFARCTION IN THE ANTERIOR PART OF THE SPINAL CORD. IT WAS NOTED THE PATIENT REQUIRED HOSPITALIZATION AND THE PATIENT OUTCOME AT THE TIME OF THIS REPORT WAS ALIVE WITH INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS UNCLEAR, BUT ATTRIBUTED TO THE LEAD. IT WAS NOTED THE PATIENT HAD MICROVASCULAR DISEASE AND A SMALL SPINAL CANAL. IT WAS NOTED THAT THERE WAS A POSSIBLE COMPRESSION OF THE DURA AND SPINAL CANAL DUE TO THE LEAD. IT WAS FURTHER NOTED AN MRI WAS DONE ON (B)(6) 2013 AND SHOWED THE PATIENT HAD SPINAL CORD ISCHEMIA AND A CONGENITALLY NARROW SPINAL CANAL. IT WAS NOTED THE LEAD WAS REMOVED IMMEDIATELY DURING THE SAME PROCEDURE ON (B)(6) 2013 AND NOT LEFT IN THE PATIENT. THE REPORTER STATED THE PATIENT HAD BILATERAL ARM WEAKNESS AND GAIT DIFFICULTIES. IT WAS NOTED THE PATIENT REMAINED IN THE HOSPITAL FOR SEVERAL DAYS. IT WAS FURTHER NOTED THE PATIENT OUTCOME WAS AN ONGOING SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351861 SPECIFY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW NEURO - VILLALBA 39565-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Hospitalization| S