BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2883213 · Received December 21, 2012

    Report

    Report Number
    3004209178-2012-12147
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    November 30, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED DUE TO PAIN AT THE DEVICE SITE. THE PATIENT WAS ALSO HAVING POSITIONAL ISSUES AND AS A RESULT WAS IMPLANTED WITH A SENSOR DEVICE. THE LOCATION WAS INDICATED TO BE UNCOMFORTABLE AS WELL AND WAS THEREFORE REVISED TO BE MORE COMFORTABLE. THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention