BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 1202187 · Received October 16, 2008

    Report

    Report Number
    3004209178-2008-06606
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 1, 2008
    Report Date
    August 31, 2016
    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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PLEASE REFER TO MANUFACTURER'S REPORT# 3004209178-2015-11525 FOR INFORMATION REGARDING BREACH OF WARRANTY FOR THE INS S/N (B)(4). INFORMATION PREVIOUSLY REPORTED IN FOLLOW UP REPORT #2 AND ANY ADDITIONAL INFORMATION RECEIVED REGARDING THE BREACH OF WARRANTY CLAIM WILL BE REPORTED IN 3004209178-2015-11525. 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 THE PT EXPERIENCED A SHOCKING OR JOLTING SENSATION. THE PT WAS LYING IN BED WHEN HE FELT THE STIMULATOR RAMP UP TO AN UNCOMFORTABLE STIMULATION SENSATION IN THE THORACIC BACK (T1-T8). THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. THE PT WAS IN A CORRECTIONAL FACILITY AND DID NOT HAVE A PT PROGRAMMER WITH HIM. THE PT WAS KEPT IN A SECURITY AREA AND THE GUARDS NEEDED TO TURN THE PT OFF. THE PT WAS TO BE IN THE FACILITY FOR APPROXIMATELY 40 DAYS. THE MANUFACTURER REPRESENTATIVE MET WITH THE PT. THE REPRESENTATIVE PALPATED ALONG THE LEAD, EXTENSION AND THE STIMULATOR. THE PT DID NOT FEEL ANY SHOCKING SENSATION. THE REPRESENTATIVE INTERROGATED THE DEVICE SYSTEM. IMPEDANCE MEASUREMENTS WERE NORMAL. THERAPY MEASUREMENTS APPEARED TO BE ACCEPTABLE. GROUP C APPEARED TO BE THE ACTIVE GROUP AT THE TIME THE EVENT OCCURRED. THE REPRESENTATIVE CONTACTED THE IMPLANT PHYSICIAN. THE PHYSICIAN WROTE A PRESCRIPTION FOR MEDICATION. THE STIMULATOR WAS TURNED DOWN TO ZERO AND OFF. THE PT STILL EXPERIENCED PAIN AFTER THE STIMULATION HAD BEEN TURNED OFF. THE LEAD SITE WAS SORE AND TENDER AROUND SHOULDER BLADES ("1/2 DOLLAR SIZE"). THE LEAD IMPLANT SITE WAS AT T3-T4. THE PT EXPERIENCED MUSCLE SPASMS IN THE DORSAL COLUMN AFTER THE INCIDENT. THE PT WAS SHAKING AND ON MEDICATION SINCE THE INCIDENT. AS OF 2008, THE MANUFACTURER REPRESENTATIVE HAD NOT RECEIVED ANY FURTHER CORRESPONDENCE FROM THE FACILITY OR THE PT. THE REPRESENTATIVE WAS UNAWARE OF THE OUTCOME OF THE EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THAT IMPLANTABLE NEUROSTIMULATOR (INS) HAD MALFUNCTIONED AND GAVE THE PATIENT SUCH A JOLT THAT IT PUT HIM IN THE HOSPITAL. IT WAS NOTED THAT THIS OCCURRED IN 2007.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED VIA THE PATIENT'S ATTORNEY REPORTED THE PATIENT INTENDS TO BRING A CLAIM AGAINST THE MANUFACTURER FOR BREACH OF WARRANTY REGARDING THEIR SPINAL CORD STIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| R LEAD MODEL 39565 LOT# N132886002| XANEX| IMPLANTED:| MEDICATIONS: OXYCODONE| ZANAFLEX| ZOMBALTA| IMPLANTED:| EXPLANTED:| EXTENSION MODEL 37081 LOT# NJB018840V| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER MODEL 37742 LOT# NJD057513N| RECHARGER SYSTEM MODEL 37752 LOT# NKA032171N| EXTENSION MODEL 37081 LOT# NJB018981V