BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME

    MDR report key: 1060647 · Received June 13, 2008

    Report

    Report Number
    3004209178-2008-03210
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    December 1, 2006
    Report Date
    December 1, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL TO UPDATE: PREVIOUS CODES NO LONGER APPLY OR HAVE BEEN UPDATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3708360, SERIAL# (B)(4). IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION, PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: 2(B)(6) 006-12-01. PRODUCT TYPE: PROGRAMMER, PATIENT PRODUCT ID: 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007-01-24. PRODUCT TYPE: EXTENSION, PRODUCT ID: 3998, LOT# V004457, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE HCP "SEVERED THE PATIENT'S ARTERY" DURING THE IMPLANT SURGERY. SINCE THEN, THE PT HAS EXPERIENCED PAIN, ITCHING AND NO PAIN RELIEF. THE PT STATES THEY ARE "WORSE OFF THAN BEFORE THE IMPLANT". NO OUTCOME WAS REPORTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THE HCP SEVERED HIS ARTERY DURING THE IMPLANT SURGERY. THE PATIENT HAD PAIN, ITCHING AND NO PAIN RELIEF AND STATED HE WAS WORSE OF THEN BEFORE THE IMPLANT. FURTHER INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT DURING THE FIRST SURGERY THE DOCTOR HAD NICKED AN ARTERY IN HIS BACK AND HE WAS SLOWLY BLEEDING TO DEATH SO THE DOCTOR REMOVED THE PADDLE AND ¿PUT HIM BACK TOGETHER¿. THE PATIENT HAD ANOTHER LEAD IMPLANTED AT A LATER DATE BUT THE NERVES HAD BEEN BOTHERED ENOUGH SO THE THERAPY NEVER TARGETED WHERE IT WAS SUPPOSED TO BE. THE PATIENT NOTED IT WAS SUPPOSED TO BE IN THE LOWER SPINE BUT WAS IN THE UPPER TORSO AND A MANUFACTURER REPRESENTATIVE TRIED TO ADJUST STIMULATION 4-5 TIMES WITHIN SIX MONTHS OF THE SECOND IMPLANT. THEY NEVER COULD GET IT TARGETED APPROPRIATELY SO THE PATIENT STOPPED USING IT. THE INDICATION FOR USE WAS CHRONIC LOW BACK PAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THE PATIENT REPORTED THAT WHILE IN RECOVERY FOLLOWING THE ORIGINAL SURGERY HE WAS EXPERIENCING MORE PAIN AND PARALYSIS. THE PATIENT REPORTED THAT THE DOCTOR WAS NOTIFIED, AND HE WAS RUSHED BACK INTO SURGERY. THE PATIENT REPORTED THAT IT SEEMED AN ARTERY HAD BEEN NICKED IN THE ORIGINAL SURGERY AND HE WAS BLEEDING INTERNALLY. THE PATIENT REPORTED THAT THE UNIT WAS REMOVED AT THAT TIME. THE PATIENT REPORTED THAT SEVEN WEEKS LATER A SECOND OPERATION ¿ ANOTHER IMPLANT. THE PATIENT REPORTED THAT HE COULD ONLY GUESS THAT NERVES WERE INJURED, RELOCATED OR WHAT? THE PATIENT REPORTED THAT AT LEAST THREE VISITS BY MANUFACTURER¿S REPRESENTATIVES (REP), AN HOUR PLUS FAILED TO DISCOVER A WAY TO MOVE THE STIMULATION FROM HIS RIB CAGE AREA TO LOWER TORSO WHERE HE NEEDED IT. THE PATIENT REPORTED THAT HE COULD SEE NO RECOURSE EXCEPT A FOURTH SURGERY. THE PATIENT REPORTED THAT THERE WERE NO FURTHER PROBLEMS AS A RESULT OF THE BLEEDING, THE UNIT REMAINED AS IS, HAD BEEN TOTALLY INACTIVE. THE ISSUE WAS RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37701 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening| R EXTENSION MODEL 37083 LOT# NKC008501N IMPLANTED| EXPLANTED| EXPLANTED| LEAD MODEL 3998 LOT# V004457 IMPLANTED| EXPLANTED| EXPLANTED| EXTENSION MODEL 37083 LOT# NKC010525N IMPLANTED| PROGRAMMER MODEL 37742 LOT# NJD034541N IMPLANTED