BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3256249 · Received July 31, 2013

    Report

    Report Number
    3004209178-2013-12546
    Event Type
    Injury
    Date Received
    July 31, 2013
    Report Date
    July 8, 2013
    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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3550-39, LOT# N250930, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3 778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED STIMULATION IN THE WRONG LOCATION. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) ¿DID NOT WORK THE WAY IT WAS SUPPOSED TO.¿ IT WAS NOTED THAT THE PATIENT WANTED TO ¿GET THE THING UP AND RUNNING AGAIN.¿ THE PATIENT STATED THAT THE INS WAS CHECKED EARLIER IN THE SPRING BUT ¿WOULD ONLY ZAP HER IN THE RIBS AND NOT IN THE LUMBAR REGION WHERE SHE NEEDED IT.¿ IT WAS NOTED THAT THE PATIENT WAS REPROGRAMMED IN THE SPRING BUT ¿IT DID NOT DO MUCH GOOD.¿ IT WAS NOTED AS A RESULT THAT X-RAYS WERE TAKEN. IT WAS NOTED THAT THE PATIENT WANTED TO USE THE INS. IT WAS NOTED THAT THE PATIENT TURNED THE INS OFF IN (B)(6) 2012 BECAUSE IT ¿DID NOT DO ANY GOOD¿ WHERE THE PATIENT NEEDED THE STIMULATION. IT WAS FURTHER NOTED THAT THE PATIENT HAD KEPT THE INS CHARGED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DOCTOR WAS CONSIDERING AN EXPLANT OF THE LEAD AND PLACEMENT OF A SURGICAL PADDLE LEAD. IT WAS NOTED THAT THERE WAS NO INFORMATION ON WHAT THE DOCTOR HAD DECIDED TO DO.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HEALTH CARE PROFESSIONAL CHOSE TO EXPLANT THE IMPLANTABLE NEUROSTIMULATOR ONLY. IT WAS NOTED THAT THE LEADS WERE LEFT IN PLACE AND COVERED WITH THE PROXIMAL END OF THE BUMPY ANCHOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS BEING EXPLANTED TOMORROW. IT WAS NOTED THAT THE PATIENT INITIALLY STATED IT HELPED AND NOW STATED THAT IT HAD NEVER HELPED. IT WAS NOTED THAT THE INS PLACEMENT WAS SUPERFICIAL AND PAINFUL AND THE PATIENT WANTED THE INS REMOVED. IT WAS NOTED THAT THE SURGEON HAD RECOMMENDED THE LEADS REMAIN. IT WAS NOTED THAT THE LEADS WERE DIRECTLY CONNECTED TO THE INS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANAGING PHYSICIAN REQUESTED THE PATIENT'S ORIGINAL FILE TO CONFIRM WHERE THE ORIGINAL LEAD WAS PLACED IN COMPARISON TO WHERE IT IS NOT. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE HAD AN APPOINTMENT ON (B)(6) 2013 TO REASSESS THE LEAD, IMPEDANCES AND REPROGRAMMING. IT WAS NOTED THAT THE PATIENT HAD BEEN SEEN BY ANOTHER MANUFACTURER REPRESENTATIVE WHO WAS UNABLE TO PROGRAM OUT OF THE NEW AREA OF SENSATION IN THE RIBS. IT WAS NOTED THIS IS NOT WHERE THE STIMULATION WAS ORIGINALLY FELT. IT WAS NOTED THAT IF IT WAS DETERMINED THAT THE LEAD HAD MOVED THE PATIENT WOULD BE REFEREED FOR A REVISION. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DECIDED THAT THE STIMULATION WAS NEVER VERY HELPFUL, EVEN FROM THE TIME OF ORIGINAL IMPLANT, AND OPTED TO HAVE IT EXPLANTED. IT WAS NOTED THAT REPROGRAMMING WAS ATTEMPTED AND WAS ABLE TO CAPTURE LOWER LIMBS BUT NOT THE LOW BACK. IT WAS NOTED THAT THE PATIENT ALSO FELT STIMULATION IN THE RIBS. IT WAS NOTED THAT BASED ON X-RAY AND DICTATION NOTES FROM THE ORIGINAL IMPLANT IT WAS DETERMINED THAT THE LEAD HAD NOT MOVED. IT WAS NOTED THAT THE PATIENT'S BATTERY WAS WORKING WELL. IT WAS NOTED THAT THE PATIENT DID NOT LIKE THE SIZE OF THE BATTERY AND WOULD LIKE EVERYTHING TAKEN OUT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT HAD BEEN AT LEAST SIX MONTHS SINCE THE PATIENT FIRST MET WITH A MANUFACTURER REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357325 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention