BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4121878 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17802
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 10, 2008
    Report Date
    September 13, 2017
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE NO LONGER APPLIES, PATIENT CODE NO LONGER APPLIES. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT SHE HAD WIRES HANGING OUT OF HER HEAD WHEN IT WAS IMPLANTED. THE PATIENT CLARIFIED THAT SHE WAS IN POST-OP WHEN THE NURSE NOTICED A LEAD WAS STICKING OUT OF THE SKIN IN THE BACK OF HER HEAD. THE PATIENT WAS BROUGHT BACK INTO SURGERY AND PUT UNDER A SECOND TIME AND THE LEAD WAS SURGICALLY REVISED TO CORRECT THE ISSUE. THE PATIENT NOTED THE FRONT LEAD WENT ACROSS HER FOREHEAD, IT WAS BARELY UNDER HER SKIN, IT WAS VISIBLE AND LOOKED LIKE A PIMPLE FORMING. THE PATIENT MENTIONED SHE COULD EXPOSE THE LEAD IF SHE SCRATCHED IT HARD ENOUGH AND THE FRONT LEAD STOPPED SHORT OF WHERE IT NEEDED TO BE. THE FRONT LEAD DID NOT SOOTHE THE NERVES LIKE THE BACK LEAD DID. THE INDICATIONS FOR USE WERE RSD/CAUSALGIA-COMPLEX REGIONAL PAIN SYNDROME AND OCCIPITAL NEURALGIA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER. IT WAS REPORTED THE DEVICE DOESN¿T COVER ALL THE PAIN. THE PATIENT STATED THE LEADS DON¿T GO OVER TO THE PAIN SITE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT HAD THE IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANTED, THE PATIENT WAS BROUGHT TO THE RECOVERY ROOM AND SHE STILL HAD WIRES STICKING OUT OF HER HEAD. THE RECOVERY ROOM NURSE HAD TO NOTIFY THE PHYSICIAN, AND THEY HAD TO TAKE HER BACK INTO SURGERY. THEN SHE GOT A SPOT WHERE IT RAN ACROSS HER FOREHEAD AND SHE COULD SEE THE END OF THE WIRE OR THE INS. SHE HAD A ¿BIG WHOLE GOB¿ OF WIRES RUNNING DOWN THE RIGHT SIDE OF HER HEAD AND THEN IT RAN ACROSS THE BACK AS WELL, BUT IT DIDN¿T RUN ALL THE WAY TO THE SPOT THAT WAS CAUSING HER PROBLEMS. ALL OF THIS HAD BEEN SINCE IMPLANT. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601311 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 00043 YR Required Intervention