BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2830650 · Received November 13, 2012

    Report

    Report Number
    3004209178-2012-10208
    Event Type
    Injury
    Date Received
    November 13, 2012
    Report Date
    October 15, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 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: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE REPORTER STATED THAT DEVICE 'REALLY NEVER' GAVE THE PATIENT 'ANY RELIEF AT ALL.' IT WAS REPORTED THAT SINCE THE DEVICE HAD BEEN IMPLANTED THE PATIENT HAD 'NOTHING BUT TROUBLE WITH HURTING MORE.' THE REPORTER STATED THAT THE PATIENT'S DOCTOR SAID THAT THE DEVICE WAS NOT WHERE IT WAS SUPPOSED TO BE. IT WAS REPORTED THAT THE DEVICE LOOKED LIKE IT WAS EITHER NOT PUT WHERE IT WAS SUPPOSED TO BE OR IT MOVED. IT WAS REPORTED THAT THE PATIENT WAS HAVING THE DEVICE REMOVED ON (B)(6) 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IN AN AUTOMOBILE ACCIDENT IN (B)(6) 2012. PRIOR TO THE ACCIDENT THE PATIENT RECEIVED APPROXIMATELY 70% PAIN RELIEF. IF THE PATIENT HAD PAIN ISSUES SHE WOULD "TAKE HER ORAL MEDICATIONS, CRANK UP HER STIMULATOR, LIE DOWN AND SHE WOULD BE FINE." SINCE THE ACCIDENT THE PATIENT'S STIMULATOR HAD BEEN SHOCKING HER "EVERY ONCE IN AWHILE, ABOUT 4 TIMES TOTAL SINCE THE ACCIDENT." THE PATIENT HAD AN X-RAY AT THE END OF (B)(6) AND IT WAS DETERMINED THAT "ALL WAS WELL." THE PATIENT SAW ONE MANUFACTURER REPRESENTATIVE WHO WAS UNABLE TO ADJUST STIMULATION AND INSTRUCTED THE PATIENT TO FOLLOW-UP WITH HER PHYSICIAN. THE PATIENT MET WITH ANOTHER MANUFACTURER REPRESENTATIVE WHO DETERMINED HER STIMULATION WAS NOT ABLE TO BE ADJUSTED BECAUSE IT WAS TURNED OFF. THE PATIENT WAS THEN ADJUSTED FROM 3 VOLTS TO 4.2 AND "THE OTHER ONE AT 0.8." IT WAS ALSO REPORTED THE PATIENT STILL HAD SPASMS BUT THEY WERE "NOWHERE NEAR AS BAD BEFORE THE SURGERY." THE PATIENT TOOK HYDROCODONE TO HELP WITH THE "BURNING" WHICH WAS NOT DIFFERENT THEN BEFORE THE SURGERY. IT WAS NOTED THE PATIENT'S STIMULATION WAS "GOOD NOW OTHER THAN THE 4 SHOCKING EPISODES." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention