BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 1216599 · Received October 30, 2008

    Report

    Report Number
    3004209178-2008-07027
    Event Type
    Injury
    Date Received
    October 30, 2008
    Date of Event
    October 3, 2007
    Report Date
    October 3, 2019
    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
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID :377760 LOT# V021353, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD, PRODUCT ID: 37752, LOT# NKA033183N, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: RECHARGER ,PRODUCT ID: 377760, LOT# V012405, IMPLANTED: (B)(6) 2008. -- PRODUCT TYPE: LEAD, PRODUCT ID :377760, LOT# V097144007, IMPLANTED: (B)(6) 2008. -- PRODUCT TYPE: LEAD. DUE TO IMDRF HARMONIZATION, SOME PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES RELATED TO THIS EVENT MAY HAVE BEEN UPDATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING LEAD REPLACEMENT, THE PATIENT HAD STIMULATION IN THE CHEST AREA AS WELL AS CRAMPING NEAR THE KIDNEY AREA. THE PATIENT ALSO EXPERIENCED SHOCKING. AN X-RAY REVEALED THE LEAD WAS AT T6. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS DETERMINED THAT THE LEAD WAS FRACTURED. THE PATIENT UNDERWENT LEAD REPLACEMENT AND REPROGRAMMING. THE PATIENT OUTCOME WAS REPORTED AS NO INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE LEADS WERE "TOO HIGH AT T6" AND ONE LEAD HAD "TURNED OFF". HOWEVER, THE PATIENT DID REPORT THE STIMULATION WAS "BETTER NOW".

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT CONTINUES TO EXPERIENCE STIMULATION IN THE WRONG LOCATION. THE PATIENT IS SCHEDULED TO HAVE A PUMP IMPLANTED. THE STIMULATION SYSTEM HAS NOT BEEN WORKING FOR THE PATIENT FOR "QUITE SOME TIME." THE PATIENT WAS REQUESTING REMOVAL OF THE STIMULATION DEVICE. THE HCP REPORTEDLY WANTED TO LEAVE THE DEVICE IN PLACE. IT WAS ALSO REPORTED THE PATIENT FELL MANY TIMES AND HAD "REVISION AND MULTIPLE REPROGRAMMINGS." SEE ALSO MFR REPORT # 3004209178-2008-04207.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TAKEN OUT BECAUSE THE PATIENT WASN¿T USING IT. SHE DID NOT USE THE INS FOR SEVERAL YEARS, IT WAS NOT WORKING/HELPING. THE INS NEVER REALLY HELPED THE PAIN AND THE VIBRATION MADE IT WORSE. A MANUFACTURER REPRESENTATIVE (REP) WORKED ON IT FOR ABOUT 2 YEARS TRYING TO FIND THE SETTINGS AND COULD NEVER GET IT TO A COMFORTABLE LEVEL. THERE WERE NO FURTHER COMPLICATIONS OR ANTICIPATIONS REPORTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention LEAD: MODEL 3777| EXPLANTED:| RECHARGER: MODEL 37752| EXPLANTED:| LEAD: MODEL 3777