BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4093142 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17096
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND THE DEVICE HAD REACHED ¿NORMAL END OF LIFE¿ WITH OKAY TELEMETRY AND OUTPUT. ¿NO ANOMALIES WERE OBSERVED WITH THE BATTERY. ALL CURRENT DRAIN VALUES WERE WITHIN SPECIFICATION. NORMAL IMPEDANCES WERE MEASURED ON ALL CIRCUITS AND ELECTRODE PAIR COMBINATIONS.¿

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO INCREASE STIMULATION WITH THEIR PROGRAMMER. AN OUT OF REGULATION (OOR), ELECTIVE REPLACEMENT INDICATOR (ERI) AND ¿CALL YOUR DOCTOR¿ MESSAGES WERE DISPLAYED. X-RAYS AND IMPEDANCE TESTING WAS PERFORMED AND A SHORT CIRCUIT WAS FOUND. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED DUE TO DEPLETION FROM AN INTERNAL SHORT. THE PATIENT OUTCOME WAS NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PATIENT WAS ¿DOING VERY WELL¿ AND WAS ¿RECEIVING EFFECTIVE THERAPY¿ AT THE TIME OF FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572555 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention