BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3150615 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-08741
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    May 16, 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

    PRODUCT ID 3777-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3777-60 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37754 LOT# SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37744 LOT# SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT¿S IMPLANTABLE PULSE GENERATOR (IPG) WAS OVERDISCHARGED. IT WAS NOTED THAT THEY COULDN¿T RUN THE IMPEDANCE OR REPROGRAM THE PATIENT¿S SETTINGS. IT WAS NOTED THAT THE PATIENT DID NOT PLAN ON RECOVERING OR RECHARGING HIS IPG. IT WAS FURTHER NOTED THAT THE PATIENT WANTED TO MEET WITH HIS PROVIDER TO HAVE HIS IPG REMOVED. IT WAS ALSO NOTED THAT THE PATIENT DIDN¿T USE IT ANYMORE AND WASN¿T INTERESTED IN USING IT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS EXPERIENCING A SHOCKING OR JOLTING SENSATION. THE PATIENT WOULD FEEL A SHOCK "AS SOON AS STIMULATION IS TURNED ON, NO MATTER WAS THE SETTING WAS SET AT". IT WAS NOTED THAT THIS BEGAN IN LATE (B)(6) 2012 TO (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT USES STIMULATION FOR HIS LOWER BACK AND LEGS. THE SHOCKING SENSATION WAS FELT AT THE LEAD SITE OR L4. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS EVENT. ADDITIONAL INFORMATION RECEIVED THE FOLLOWING DAY REPORTED THAT THE PATIENT HAD NOT CHARGED THEIR DEVICE OR USED IT "IN MONTHS". THE PATIENT NEEDED TO RECHARGE THE DEVICE BEFORE IT COULD BE REPROGRAMMED OR INTERROGATED. IT WAS STATED THAT THE PATIENT WAS ALIVE WITH NO ADVERSE EVENT OR INJURY. ABOUT TWO WEEKS LATER IT WAS STATED THAT THE PATIENT HAS NOT MET WITH A COMPANY REPRESENTATIVE TO HAVE THEIR DEVICE INTERROGATED OR CHECKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249942 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 00027 YR