BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR MRI

    MDR report key: 4192357 · Received October 22, 2014

    Report

    Report Number
    3004209178-2014-20140
    Event Type
    Injury
    Date Received
    October 22, 2014
    Report Date
    October 1, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF NEUROSTIMULATOR MODEL 37714, SERIAL # (B)(4) SHOWED NO SIGNIFICANT ANOMALIES AND WAS FUNCTIONALLY OKAY.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 977A275, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 977A275, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. (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 REPORTED THE BATTERY HAD PREMATURE DEPLETION. THE BATTERY WAS NOT HOLDING A CHARGE AND WAS JOLTING. THE PATIENT REPORTED A SHOCKING AND JOLTING SENSATION. IMPEDANCE TESTING WAS PERFORMED (RESULTS NOT REPORTED) AND SURGICAL INTERVENTION WAS REQUIRED. THE BATTERY WAS EXPLANTED ON (B)(6) 2014 AND REPLACED WITH A DIFFERENT PRODUCT. NO COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT¿S STATUS WAS NOTED TO BE ALIVE WITH NO INJURY AT THE TIME OF THIS REPORT. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL FOLLOW-UP IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS DOING GREAT AND WAS DOING REALLY GOOD WITH THE THERAPY AS WELL. THERE WERE NO OTHER ISSUES SINCE THE REPLACEMENT OF THE IMPLANTABLE NEUROSTIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673912 RESTORE SENSOR MRI STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention