BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3214530 · Received July 9, 2013

    Report

    Report Number
    3007566237-2013-02289
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 24, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A PERIPHERAL NERVE EVALUATION (PNE) INTERSTIM THERAPY TRIAL. THE TRIAL WAS INCONCLUSIVE AND THE PATIENT DID NOT GET THE IMPLANT. IT WAS LATER REPORTED THAT THE PATIENT HAD A STIMULATOR TRIAL PROCEDURE PERFORMED ON (B)(6) 2013. IT WAS NOTED THAT THE PATIENT EXPERIENCED ¿HURT¿ DURING THE PROCEDURE. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED FEELING ¿SO SICK¿, DIZZY, NAUSEA AND VOMITING AFTER THE PROCEDURE. IT WAS NOTED LATER THAT AFTERNOON OF THE PROCEDURE, THE PATIENT WENT TO THE EMERGENCY ROOM AFTER THE PATIENT CHECKED BLOOD PRESSURE. THE READING WAS AT 240/100. THE PATIENT WERE GIVEN SHOTS FOR BLOOD PRESSURE AND NAUSEA AND IT WAS NOTED THAT IT DID WORK. IT WAS NOTED THAT THE PATIENT BLOOD PRESSURE CONTINUED TO INCREASE AND THE PATIENT WENT BACK TO THE EMERGENCY ROOM THREE DAYS AFTER THE PROCEDURE. IT WAS NOTED THE NEXT DAY THAT THE PATIENT WENT TO SEE THE HEALTHCARE PROVIDER AND THE¿WIRES¿ WERE REMOVED. THE PATIENT LATER HAD BLOOD PRESSURE CHECKED BY ANOTHER HEALTHCARE PROVIDER AND THE BLOOD PRESSURE READINGS WERE LOWERING EVERY TEN MINUTES. IT WAS NOTED THAT THE PATIENT¿S BLOOD PRESSURE HAS BEEN STABLE AS OF (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE TRIAL WAS INCONCLUSIVE DUE TO THE PATIENT TURNED THE STIMULATOR BOX OFF WITHIN 24 HOURS OF THE THERAPY. IT WAS NOTED THAT THE PATIENT EXPERIENCED HIGH BLOOD PRESSURE DURING THE TRIAL. IT WAS ALSO NOTED THAT THE PATIENT REFERENCED THAT THE TEST MAY HAVE CAUSED THE HIGH BLOOD PRESSURE. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STARTED THE TRIAL ON (B)(6) 2013. THE PATIENT CALLED THE CLINIC ON (B)(6) 2013 COMPLAINING OF NAUSEA, DIZZINESS, VOMITING, AND HIGH BLOOD PRESSURE. THE PATIENT HAD A FOLLOW-UP APPOINTMENT ON (B)(6) 2013, BUT THE PATIENT CANCELLED THE APPOINTMENT. THE HEALTHCARE PROVIDER (HCP) HAD NOT SEEN THE PATIENT SINCE. IT WAS UNKNOWN IF THE SYMPTOMS WERE CONSIDERED DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313415 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention