BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME

    MDR report key: 3103615 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07482
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 22, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF NEUROSTIMULATOR MODEL 37701, SERIAL # (B)(4) SHOWED NO SIGNIFICANT ANOMALIES.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3487A-45, LOT# VA03QZD, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3487A-45, LOT# VA03QZD, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE STIMULATOR WAS REPLACED ON (B)(6) 2013. THERE WERE IMPEDANCES GREATER THAN 3600 OHMS ON ALL ELECTRODES. THE STIMULATOR WAS REPLACED WITH A 37713 AND AN EXTENSION WAS ADDED. POST PROCEDURE IMPEDANCES WERE ALL LESS THAN 3000 OHMS. THE PATIENT RECEIVED GOOD POST OPERATIVE STIMULATION AND WAS NOTED TO BE "HAPPY." THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE. IT WAS ADDED A MANUFACTURER REPRESENTATIVE CHANGED PROGRAMMING TO CYCLING TO CONSERVE THE BATTERY. IT WAS NOTED THE PATIENT WAS UNABLE TO FEEL STIMULATION WHEN SHE USED CYCLING. IT WAS ADDED THE PATIENT CHANGED TO A NON-CYCLING GROUP AND THE STIMULATION WAS 'OK.' IT WAS STATED THE IMPLANTABLE NEUROSTIMULATOR'S (INS) BATTERY VOLTAGE WAS 2.9 VOLTS. IT WAS NOTED THERE MAY HAVE BEEN A FALSE ERI DUE TO A POSSIBLE INTERMITTENT SHORT. IT WAS STATED THAT DURING THE IMPLANT THE TWO QUAD LEADS WERE CONNECTED DIRECTLY TO THE INS WITHOUT USING EXTENSIONS. IT WAS ADDED THE DOCTOR PLANS TO REPLACE THE INS WITH A RECHARGEABLE INS AND ADD EXTENSIONS. IT WAS REPORTED A FEW DAYS LATER THE PATIENT WAS RECEIVING EFFECTIVE THERAPY AND WAS SCHEDULE FOR A REPLACEMENT INS ON (B)(6) 2013. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204519 RESTORE PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37701

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention