BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3232691 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11929
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 23, 2013
    Report Date
    June 25, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT AT THE LAST VISIT WITH THE MANUFACTURER¿S REPRESENTATIVE THAT DURING INTERROGATION, IMPEDANCES CHECKED OUT FINE ON THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS ALSO NOTED THAT THE PATIENT DESIRED TO HAVE THE INS SYSTEM REMOVED BECAUSE IT WAS NOT HELPING THEIR PAIN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WOULD BE REMOVED. IT WAS NOTED THAT IT STOPPED WORKING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE STIMULATION WAS TURNED ON THE PATIENT REPORTED NO STIMULATION SENSATION. IT WAS NOTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. IT WAS FURTHER NOTED THAT THE PATIENT STARTED NOT HAVING THERAPY "YESTERDAY OR MAYBE 2 DAYS" PRIOR TO REPORT. IT WAS NOTED THAT THE PATIENT LAST CHARGED OVER THE WEEKEND AND THAT SHE HAD TO KEEP INCREASING THE STIMULATION TO EVEN FEEL ANYTHING. IT WAS FURTHER NOTED THAT THE PATIENT USED TO BE AROUND 4 VOLTS BUT THAT NOW SHE IS UP TO 9.70 VOLTS. IT WAS NOTED THAT THE PATIENT ONLY HAD ONE GROUP TO WORK WITH.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WISHED TO HAVE THE UNIT EXPLANTED AND THE EXPLANT WAS SCHEDULED FOR (B)(6) 2013. IT WAS NOTED THAT IT WOULD BE AN OUT PATIENT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333103 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 00075 YR Required Intervention