BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3061963 · Received April 16, 2013

    Report

    Report Number
    3004209178-2013-06385
    Event Type
    Injury
    Date Received
    April 16, 2013
    Report Date
    April 1, 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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3550-29, LOT# N310675, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: ACCESSORY: PRODUCT ID 3550-39, LOT# N346374, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS SCHEDULED FOR A LEAD AND POSSIBLE POCKET REVISION (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED APPROXIMATELY 2 WEEKS LATER REPORTED THE LEAD WAS EXPLANTED AND THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. IT WAS UNCLEAR IF A POCKET REVISION OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD INTERMITTENT STIMULATION. THE REPORTER STATED THAT THE PATIENT'S DEVICE WAS INTERROGATED AND THE IMPEDANCE CHECK SHOWED THAT CONTACTS 2 AND 3 HAD IMPEDANCES GREATER THAN 10000 OHMS. THE PATIENT WAS REPROGRAMMED WITHOUT USING THESE CONTACTS AND WAS ABLE TO GET EFFECTIVE PARASTHESIA. IT WAS REPORTED THAT THE PATIENT DID NOT HAVE ANY KNOWN TRAUMATIC EVENT THAT MAY HAVE LED TO THE ELECTRODE ISSUE. THE REPORTER STATED THAT THE PATIENT WOULD LET HIS PHYSICIAN KNOW ABOUT THE EFFECTIVENESS OF HIS STIMULATION AND SUBSEQUENT PAIN RELIEF. TWO DAYS LATER, IT WAS INDICATED THAT THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPEUTIC STIMULATION AND PAIN RELIEF. IT WAS REPORTED THAT THE PATIENT WAS GOING FOR A CONSULT FOR A REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162334 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 Required Intervention