BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2291678 · Received August 16, 2011

    Report

    Report Number
    6000032-2011-06451
    Event Type
    Injury
    Date Received
    August 16, 2011
    Report Date
    August 30, 2011
    Manufacturer
    MEL REL, HUMACAO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEADS WERE "DISLODGED" FOLLOWING AN UNSPECIFIED COMPLICATION THAT OCCURRED DURING AN UNRELATED SPINAL FUSION SURGERY. THE PATIENT EXPERIENCED A "SHOCKING" SENSATION AT THE LEAD SITE. WHEN THE PATIENT MET WITH THE MANUFACTURER REPRESENTATIVE "A COUPLE OF YEARS AGO," IT WAS SUGGESTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR BATTERY WAS DEPLETED. THE PATIENT'S DEVICE AND LEAD WERE SCHEDULED TO BE EXPLANTED ON (B)(6) 2011. NO INFORMATION WAS PROVIDED RELATED TO THE PATIENT'S OUTCOME. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION. THE HEALTH CARE PROFESSIONAL STATED THE PATIENT FELT "OCCASIONAL" ELECTRIC SHOCKS DOWN THE RIGHT LEG, AND THE PATIENT HAD ONGOING SEVERE PAIN. THE RIGHT LEG PAIN "SEEMED" TO HAVE BEEN HELPED FOLLOWING THE SURGERY, BUT IT WAS UNCLEAR WHAT SURGERY THE HCP WAS REFERENCING. THE HCP REPORTED THE STIMULATOR HAD NOT BEEN WORKING SINCE THE SPINAL FUSION SURGERY. AN X-RAY WAS TAKEN, AND THE RESULTS SHOWED THE STIMULATOR HAD MIGRATED DOWN FROM THE T11, 12 LEVEL TO THE L2, 3 LEVEL. THE STIMULATOR WAS ALSO IRRITATING THE PATIENT'S ABDOMINAL REGION, AND THE PATIENT WANTED THE DEVICE REMOVED. THE ENTIRE STIMULATOR SYSTEM WAS REMOVED WITHOUT ANY PROBLEMS, AND THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEL REL, HUMACAO 7427V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention LEAD: MODEL UNK, LOT# UNK| EXTENSION: MODEL UNK, LOT# UNK| IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT026089P| EXPLANTED: