BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2850309 · Received November 29, 2012

    Report

    Report Number
    3004209178-2012-10901
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 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 3888-56, LOT # V125558, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3887-56, LOT # V115220, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3776-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER; PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A SUSPECTED OVERDISCHARGE. THIS WAS AT LEAST THE 2ND OVERDISCHARGE EVENT THAT THE REPORTER WAS AWARE OF, THOUGH THERE WAS CONCERN OF IT BEING HIS 3RD. IT WAS NOTED THAT PATIENT COMPLIANCE, DUE TO DISSATISFACTION WITH STIMULATION, WAS THE PRIMARY REASON FOR OVERDISCHARGE . THE LAST TIME STIMULATION WAS FELT AND THE LAST SUCCESSFUL RECHARGE SESSION WERE OVER A YEAR PRIOR TO REPORT. A SEPARATE REPORT ON THE SAME DAY STATED THAT THE PATIENT HAD DONE EIGHT PHYSICIAN RECHARGE MODE (PRM) SESSIONS WITH NO SUCCESS. IT WAS NOTED THAT THE STIMULATOR WAS "A LITTLE DEEP, BUT NOT TOO DEEP." THERE WERE ALSO QUESTIONS AS TO IF THE STIMULATOR WAS FLIPPED, THOUGH THE PATIENT BELIEVED THAT IT WASN'T. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO MALFUNCTIONS SEEN AND THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE REPORTER STATED THAT THE PATIENT WAS SHOWN HOW TO TAKE THE DEVICE OUT OF OVERDISCHARGE. IT WAS REPORTED THAT THE PATIENT WOULD PROBABLY ELECT NOT TO CONTINUE WITH THE THERAPY AND WAS TALKING WITH THE DOCTOR ABOUT A DIFFERENT THERAPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THE LAST TIME THEY WERE OVERDISCHARGED THEY WERE NOT ABLE TO SUCCESSFULLY BRING THE IMPLANTABLE NEUROSTIMULATOR BACK. THE INDICATION FOR USE WAS POST LUMBAR LAMINECTOMY SYNDROME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE SENT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 61 YR