BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3590998 · Received January 24, 2014

    Report

    Report Number
    3004209178-2014-01110
    Event Type
    Injury
    Date Received
    January 24, 2014
    Date of Event
    November 7, 2012
    Report Date
    January 3, 2014
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: RECHARGER. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. 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. PRODUCT ID: 377760, LOT# V010175, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377760, LOT# V010175, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD ISSUES WITH HIS DEVICE SINCE IMPLANT. THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND STIMULATION IN THE WRONG LOCATION. THE PATIENT STATED HE WAS HURTING ALL THE TIME AND THE STIMULATOR DID NOT WORK LIKE IT SHOULD/DIDN¿T WORK. THE DEVICE HURT WHEN THE PATIENT BENT OVER. THE PATIENT STATED HIS NERVOUS SYSTEM AND TISSUE WAS ¿MESSED UP.¿ THE PATIENT WAS ALSO UNABLE TO SLEEP. THE PATIENT USED PEPPERS (JALAPENOS, ETC) TO HELP OVERRIDE PAIN AS HE NO LONGER HAD HYDROCODONE FOR PAIN. THE DEVICE HAD BEEN MOVED AT SOME POINT FROM HIS HIP TO HIS ABDOMEN (UNABLE TO PROVIDE THE DATE, ONLY STATED AS A FEW YEARS BACK). THE PATIENT WAS REDIRECTED TO A PHYSICIAN TO HAVE HIS DEVICE CHECKED. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57750 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention