BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3251592 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-12395
    Event Type
    Injury
    Date Received
    July 29, 2013
    Report Date
    July 12, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF NEUROSTIMULATOR MODEL 37714 SERIAL # (B)(4) SHOWED NO SIGNIFICANT ANOMALIES AND SHOWED A REDUCED BATTERY CAPACITY DUE TO AN OVERDISCHARGE CONDITION (WHICH WAS RECOVERED NORMALLY FOR TESTING). A RECHARGE COUPLING TEST PERFORMED HAD RESULTS THAT MATCHED THOSE OF A KNOWN GOOD NEUROSTIMULATOR WITH NO RECHARGING ISSUES OBSERVED. (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 INITIALLY REPORTED THAT THE PATIENT HAD COUPLING ISSUES WHEN TRYING TO RECHARGE THEIR IMPLANTABLE NEUROSTIMULATOR (INS). USE OF THE ANTENNA LOCATOR (AL) FEATURE SHOWED COUPLING OF BETWEEN 34 TO 48 WITH NO SUCCESS OF GETTING ANY COUPLING BARS AND CONTINUED TO SEE THE POOR COMMUNICATION SCREEN ON THE RECHARGER. IT WAS NOTED THAT THE PATIENT LAST FELT THE STIMULATION ABOUT 1 MONTH AGO AND HAD NOT CHARGED IN OVER 6 WEEKS. THE PATIENT DID ATTEMPT TO CHARGE ABOUT 2 WEEKS AGO AND DID NOT GET ANY COUPLING BARS. ADDITIONAL INFORMATION RECEIVED ON REPORTED THAT THE INS WAS EXPLANTED AND REPLACED DUE TO A COMPLAINT OF THE DEVICE NOT WORKING FOR 6 MONTHS. IT WAS ALSO NOTED THAT THERE WAS NORMAL DEPLETION OF THE INS BATTERY. THERE WERE NO PATIENT INJURIES AND THE OUTCOME REPORTED AS RECOVERED WITHOUT SEQUELAE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352509 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Required Intervention