BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2538412 · Received April 17, 2012

    Report

    Report Number
    3004209178-2012-02415
    Event Type
    Injury
    Date Received
    April 17, 2012
    Report Date
    March 22, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: UNKNOWN. PRODUCT ID: 3998, LOT# V011699, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION.

    Additional Manufacturer Narrative · 1

    LEAD MODEL: 3998, LOT#: V011699, IMPLANTED: (B)(6) 2006, EXPLANTED: NA. EXTENSION MODEL: 3708360, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: NA. EXTENSION MODEL: 3708360, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: NA. ADAPTOR MODEL: UNK, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: NA. PROGRAMMER MODEL: 37742, SERIAL#: (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT ON HER LEFT SIDE BUT STILL HAD ADEQUATE PAIN RELIEF ON THE RIGHT SIDE. THE PATIENT NOTED SHE HAD EXPERIENCED A FALL WHERE SHE HIT HER SHOULDER BUT DID NOT NOTICE ANY EFFECTS AT THAT TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS REGARDING HER DEVICE OR THERAPY. THE PATIENT HAD THEIR DEVICE REPLACE ON (B)(6) 2012 AND IT WAS "GREAT SO FAR". THE PATIENT HAD AN APPOINTMENT IN (B)(6) 2012. IT WAS ALSO STATED THAT THE PATIENT WAS WORKING WITH THEIR HEALTH CARE PROVIDER AND MEDTRONIC REPRESENTATIVE REGARDING CONCERNS. THE PATIENT HAD APPOINTMENTS SCHEDULED FOR (B)(6) 2013 AND (B)(6) 2013. ONE WEEK LATER IT WAS REPORTED THAT THE PATIENT HAD A POST-OPERATIVE APPOINTMENT ON (B)(6) 2013 WHERE THEY MET WITH A MEDTRONIC REPRESENTATIVE. IT WAS STATED THAT THE PATIENT WAS "DOING WELL AND RECEIVING EFFECTIVE THERAPY." THE PATIENT WAS GOING TO BE SEEN ON (B)(6) 2013 TO HAVE HER BATTERY ACTIVATED FOR ADAPTIVE STIMULATION. IT WAS STATED THAT THERE WERE NO KNOWN CAUSES OF THE ISSUE OR MALFUNCTIONS SEEN. LATER THAT DAY IT WAS REPORTED THAT THE PATIENT HAD THEIR ADAPTIVE STIMULATION ACTIVATED. THE PATIENT WAS RECEIVING "GOOD" THERAPY AND NO REPROGRAMMING WAS NECESSARY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention