BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3973899 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13860
    Event Type
    Injury
    Date Received
    August 1, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING URINARY INCONTINENCE AND RETENTION ISSUES SINCE THE IMPLANT. THE PATIENT SAW A UROLOGIST WHO FELT THAT THE STIMULATOR WAS THE LIKELY CAUSE OF THE URINARY SYMPTOMS. THE PATIENT STATED IT DIDN¿T MAKE A DIFFERENCE WHETHER OR NOT THE STIMULATOR WAS ON OR OFF WHEN SHE HAD THE SYMPTOMS. THE PATIENT PLANNED TO FOLLOW UP WITH HER UROLOGIST. THERE WERE NO ISSUES WITH THE STIMULATOR, RECHARGING WAS SUCCESSFUL AND ALL IMPEDANCES WERE WITHIN RANGE. IT WAS FURTHER REPORTED THAT THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. THE PATIENT RECOVERED WITH NO SEQUELAE. FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN AND THAT THERE WERE NO ERROR MESSAGES. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WOULD BE HAVING THE SYSTEM EXPLANTED ON (B)(6).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE MANUFACTURER REPRESENTATIVE WAS NOT ABLE TO ATTEND THE EXPLANT. THE PATIENT OUTCOME WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451107 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention