BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2872944 · Received December 13, 2012

    Report

    Report Number
    3004209178-2012-11815
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    November 21, 2012
    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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION. PRODUCT ID 3550-29, LOT# N153474, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. AFTER A BATTERY REPLACEMENT SURGERY IT WAS STATED THAT THE PATIENT FELT AN "EXTRA JOLT" EVERY TIME HE TOOK A STEP. IT WAS REPORTED THAT THE DEVICE ONLY WORKED IF PRESSURE WAS APPLIED TO IT. IT WAS NOTED THAT THE PATIENT WENT TO THE DOCTOR AND WAS REPROGRAMMED. THEN IN (B)(6) IT WAS STATED THAT THE "BOX QUIT WORKING ALL TOGETHER". THE PATIENT HAD SURGERY AND IT WAS DISCOVERED THAT THERE WAS A LEAD FRACTURE. FURTHER INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF MORE INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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