BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3083461 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-07035
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 12, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THEIR LEAD EXPLANTED AND REPLACED. IT WAS FURTHER REPORTED THAT THE PATIENT HAD POST-OPERATIVE HIP PAIN AND A CT SCAN SHOWED THAT THERE WAS NOT ENOUGH SPACE TO SUPPORT AND CAUSED PAIN. IT WAS NOTED THAT SURGICAL INTERVENTION WAS REQUIRED AND THE HEALTH CARE PROVIDER MADE A LARGER LAMINECTOMY TO ALLOW MORE ROOM FOR THE LEAD. IT WAS NOTED THAT THE PATIENT WAS ALIVE WITH INJURY. IT WAS LATER REPORTED THAT THE HIP PAIN HAD RESOLVED BUT A THOROUGH REPROGRAMMING FOR THE PATIENT'S ORIGINAL PAIN HAD NOT YET BEEN DONE DUE TO NORMAL POST-OPERATIVE PAIN. IT WAS LATER REPORTED THAT THE PATIENT'S FOOT PAIN WAS COVERED AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184517 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention