BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2955689 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02531
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    January 24, 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

    ANALYSIS OF THE NEUROSTIMULATOR MODEL 37713 SERIAL (B)(4) FOUND NO SIGNIFICANT ANOMALY. THE BATTERY HAD REDUCED CAPACITY DUE TO OVERDISCHARGE. ANALYSIS OF THE LEADS MODEL 3778-60 LOTS V557249020 AND V530605003 FOUND NO SIGNIFICANT ANOMALY. THE LEAD BODIES WERE CUT THROUGH AND THE PRODUCTS SEGMENTED. CONTINUITY WAS ACCEPTABLE ON THE RETURNED SEGMENTS.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED SHOCKING IN THE POCKET AND HAD "INCREASING AMOUNT OF STATIC ELECTRICITY" PRIOR TO THE DEVICE BEING EXPLANTED. IT WAS STATED THAT ONCE THE PATIENT'S DEVICE WAS REMOVED, THERE WERE NO MORE REPORTS OF STATIC SHOCKING. IT WAS NOTED THAT THE PATIENT DID NOT HAVE AN INJURY. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN 'INCREASE IN STATIC ELECTRICITY SHOCK.' IT WAS STATED THAT THE PATIENT WOULD 'ALWAYS TOUCH AN OBJECT AND COULD SEE A 1-INCH SPARK OFF THE TIP OF HIS FINGER.' THE PATIENT REPORTEDLY NEEDED AN MRI, BUT PHYSICIAN WANTED BATTERY LOOKED AT. PATIENT WAS REPORTED AS ALIVE WITH NO INJURY AND NO ADVERSE EVENT. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR WAS EXPLANTED. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58707 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention