BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3122804 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-07998
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    December 16, 2009
    Report Date
    May 2, 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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3887-33, LOT# L71690, IMPLANTED: (B)(6) 1999, PRODUCT TYPE LEAD; PRODUCT ID 3887-33, LOT# L70361, IMPLANTED: (B)(6) 1999, PRODUCT TYPE LEAD; PRODUCT ID 3887-33, LOT# J0007967V, IMPLANTED: (B)(6) 2000, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 74001, LOT# N202534, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ADAPTER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF RIGHT UPPER QUADRANT GENERATOR POCKET ON (B)(6) 2009. IT WAS STATED THAT SUBCUTANEOUS FAT WAS RESECTED TO MAKE THE GENERATOR MORE ACCESSIBLE TO THE PATIENT PROGRAMMER. THE PATIENT WAS LAST SEEN ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225016 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 00045 YR Required Intervention