BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3792094 · Received May 6, 2014

    Report

    Report Number
    3004209178-2014-08537
    Event Type
    Injury
    Date Received
    May 6, 2014
    Report Date
    March 22, 2016
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 377845, LOT # V009012, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 377845, LOT # V009012, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE NO LONGER APPLIES. DEVICE CODE (B)(4) NO LONGER APPLIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD TWO REVISIONS SINCE THE DEVICE WAS IMPLANTED AND STILL HAD IRREGULAR STIMULATION IN THE WRONG AREA. IT WAS NOTED THAT THE LAST REVISION WAS DONE ABOUT THREE YEARS AGO AND SINCE ¿NO ONE WAS HELPING¿ THE PATIENT WITH THIS PROBLEM, SHE HADN¿T RETURNED SINCE. THE REPORTER STATED THAT THE PATIENT WAS FIRST TOLD THAT THE SPINAL CANAL WAS TOO LARGE AND THE LEADS MIGRATED, BUT DURING THE REVISION THE DOCTOR COULD NOT GET THE LEADS HIGH ENOUGH AND STATED THAT THE CANAL WAS TOO SMALL AND HE COULDN¿T GET THEM TO MOVE. IT WAS NOTED THAT DURING THE SURGERY THE DOCTOR ASKED OVER AND OVER FOR A ¿SMALLER NUMBER 8¿ TO MOVE IT BUT THEY COULDN¿T FIND ONE. IT WAS REPORTED THAT THE PATIENT HAD LOST CONFIDENCE IN THE CLINIC AND HAD NO IDEA WHERE TO GO OR IF ANYTHING COULD BE DONE TO CORRECT THE MIGRATION. IT WAS NOTED THAT WHEN THE LEADS WERE IN THE CORRECT AREA THE PATIENT GOT GOOD RESULTS AND PAIN CONTROL, BUT SHE HAD OTHER HEALTH ISSUES, WAS UNABLE TO GET AN MRI, AND WAS CONFUSED IF THE DEVICE WAS WORTH KEEPING. THE REPORTER STATED THAT THE PATIENT HAD SELDOM OR ALMOST NEVER USED THE DEVICE IN THE PAST THREE YEARS AND HAD ¿NO IDEA WHERE TO GO FROM HERE.¿ IT WAS LATER REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH HER DEVICE OR THERAPY BUT HAD NOT SOUGHT FURTHER HELP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THEIR IMPLANTABLE NEUROSTIMULATOR HAD REACHED EOS AND SHE DID NOT WISH TO HAVE A NEW BATTERY IMPLANTED. THE PATIENT REPORTED THAT SHE HAD 2 REVISIONS AND THE LEADS WEREN'T REPLACED WELL SHE WAS TOLD DUE TO A NARROW SPINAL CANAL, ALTHOUGH THEY MIGRATED IN THE FIRST PLACE BECAUSE THE CANAL WAS TOO LARGE. THE PATIENT WAS IMPLANTED WITH A NEUROSTIMULATOR FOR FAILED BACK SURGERY SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270321 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 00055 YR Required Intervention