BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3103385 · Received May 9, 2013

    Report

    Report Number
    3004209178-2013-07487
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    November 1, 2011
    Report Date
    May 6, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3998, LOT# J0527051V, IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD: PRODUCT ID 37743FA, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PHYSICIAN DID NOT KNOW THE CAUSE OF THE EVENT. THE PHYSICIAN CONFIRMED THE SHOCKING/JOLTING SENSATION. IT WAS UNKNOWN IF THERE WERE ANY ABNORMAL IMPEDANCES. THE DEVICE WAS REPROGRAMMED ON 2013 (B)(6) BY A COMPANY REPRESENTATIVE. THE PATIENT¿S PAIN LEVEL DECREASED TO 5 OUT OF 10. THE PATIENT WAS NOT HOSPITALIZED AND THE OUTCOME WAS LISTED AS NO INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT SHE FELT STIMULATION IN THE WRONG LOCATION IN (B)(6) 2011. STIMULATION MOVED OVER TO THE RIGHT ARM EVEN THOUGH IT WAS SUPPOSED TO BE IN THE LEFT ARM. THE PATIENT ALSO FELT ACUTE PAIN IN THE RIGHT ARM IN (B)(6) 2011. THE PATIENT WENT TO THE E.R. AT THAT TIME DUE TO THE PAIN. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE START OF THE PAIN OR STIMULATION IN THE WRONG LOCATION. THE PATIENT STILL HAD GOOD PAIN CONTROL ON THE LEFT ARM. ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE PATIENT EXPERIENCED A SHOCKING SENSATION. THE PATIENT HAD PAINFUL SHOCKING THAT OCCURRED INTERMITTENTLY. SHE WAS ALSO IN PAIN BECAUSE SHE DECREASED THE STIMULATION AMPLITUDE TO TRY AND MANAGE THE SHOCKING SO THE THERAPY WAS NOT WORKING AS WELL FOR HER PAIN COVERAGE. IT WAS ALSO NOTED THAT AT TIMES THE PATIENT'S RIGHT LEG WOULD GO NUMB. THE PATIENT STATED THAT THE SHOCKING SENSATION OCCURRED "IN CERTAIN POSITIONS" AND BEGAN IN (B)(6) 2012. THE PATIENT NOTED THAT SHE HAD MET WITH HER PHYSICIAN IN (B)(6) 2012 AND HE HAD STATED THAT THERE MAY BE AN ISSUE WITH THE INS, BUT NO REPLACEMENT WAS SCHEDULED OR PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204218 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR