BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4080386 · Received September 11, 2014

    Report

    Report Number
    3004209178-2014-16772
    Event Type
    Injury
    Date Received
    September 11, 2014
    Report Date
    October 7, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 39286-65, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID: 3550-39, LOT# N202832, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2009 THE PATIENT WAS GETTING AN IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM PLACED IN HER C-SPINE, HOWEVER, SOMETHING WENT WRONG AND THEY HAD TO REMOVE IT. AS A RESULT, SHE EXPERIENCED PARALYSIS FOR A WHILE IN HER ARMS AND FINGERS AND HAD TO RELEARN EVERYTHING. HOWEVER, THE PATIENT¿S HEALTHCARE PROVIDER (HCP) DID NOT SEE A MENTION OF PARALYSIS IN THE PATIENT¿S RECORDS. THERE WAS A PATIENT CHART AND PROGRESS NOTE FROM (B)(6) 2009 THAT DID NOT HAVE SERIAL NUMBERS AND ALSO DID NOT MENTION PARALYSIS, BUT NOTED THE PATIENT HAD PAIN IN THE ARMS AND NUMBNESS IN THE FINGERS. THE RECORDS WAS ALSO ¿INDICATING PATIENT HAD STIMULATOR IMPLANT¿, BUT IT WAS UNCLEAR IF THAT INS WAS REFERRING TO THE INS THAT WAS ALREADY IMPLANTED ON (B)(6) 2008 OR THE INS THAT WAS ATTEMPTED TO BE IMPLANTED IN (B)(6) 2009. ADDITIONAL RECORDS SHOWED THAT ONE X-RAY AND ONE FLUORO, LASTING 65 SECONDS, WERE TAKEN; THE PATIENT WAS NOT SHIELDED. DERMABOND ISLAND DRESSING WAS APPLIED AT THE POSTERIOR NECK AND LEFT BUTTOCK. TWO BANDAIDS WERE APPLIED TO MID BACK, AND NO DRAINS OR LASERS WERE USED. THE PATIENT WAS ADMITTED ON (B)(6) 2009 FOR AN UNKNOWN DURATION OF TIME. IT WAS NOTED THAT THERE WAS SPACE IN HER C-SPINE AND THAT WAS WHY SHE WAS TRYING STEROID INJECTIONS. BECAUSE THE PATIENT COULD NOT HAVE AN INS SYSTEM IN HER C-SPINE, SHE WAS TAKING ORAL MEDICATION FOR PAIN IN THIS AREA. 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. REFER TO MANUFACTURING REPORT #3004209178-2014-16674 AND 3004209178-2014-16687

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT REGARDING THE IMPLANT WHERE THE DOCTOR "DID SOMETHING" AND PARALYZED THE PATIENT. IT WAS REPORTED THAT, EVEN AFTER WORKING ON IT FOR ALL THESE YEARS, THE PATIENT STILL HAD AN ISSUE WITH HER ARM FROM THE PROCEDURE. PARALYZING SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562026 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 Hospitalization| O