BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 4245070 · Received November 12, 2014

    Report

    Report Number
    3004209178-2014-21374
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Report Date
    October 22, 2014
    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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37742, SERIAL# (B)(4) IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 377875, LOT# V003908, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377875, LOT# V002830, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE MANUFACTURER REPRESENTATIVE MET WITH THE PATIENT ON 2014-(B)(6) AND REPROGRAMMING WAS PERFORMED AND IMPEDANCES SHOWED EVERYTHING WAS WITHIN NORMAL LIMITS. AT THE END OF THE APPOINTMENT THE PATIENT LEFT HAPPY. IT WAS FURTHER NOTED THE PATIENT¿S DEVICE WAS NEARING END OF LIFE (EOL) AND WAS SCHEDULED FOR REPLACEMENT THE WEEK OF (B)(6) 2014 DUE TO NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SHOCKING OR JOLTING SENSATION. THE PATIENT STATED THE STIMULATOR WAS NOT WORKING AND IT WAS SHOCKING HER, WHICH STARTED THE WEEK PRIOR TO THE REPORT. IT WAS NOTED THE PATIENT FELL ON MONDAY, (B)(6) 2014, BUT SHE GOT SHOCKED BEFORE SHE FELL ON MONDAY MORNING. THE STIMULATOR WAS OFF WHEN SHE WAS GETTING SHOCKED. THE PATIENT WAS NOT FEELING GOOD AND LYING ON THE COUCH WHEN SHE GOT SHOCKED. THE PAIN LASTED A WHILE AND IT WAS RIGHT OVER THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THE PATIENT HAD TO RUB HER BUTT OUT TO GET THE PAIN TO RESOLVE. THE PATIENT REPORTED SHE SAW HER HEALTHCARE PROVIDER (HCP) THE DAY OF THE REPORT FOR FURTHER BACK PROBLEMS. THE ADDITIONAL BACK PROBLEMS STARTED THREE MONTHS PRIOR TO THE REPORT. ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP) STATED THAT THE SHOCKING STARTED A MONTH PRIOR TO (B)(6) 2014. IT WAS REPORTED THAT THERE HAD BEEN NO FALLS (EVEN THOUGH A FALL HAD PREVIOUSLY BEEN REPORTED.) THE HCP WAS UNSURE IF THE DEVICE WAS ON OR OFF. IT WAS SUGGESTED TO SCHEDULE A MEETING WITH THE MANUFACTURER¿S REPRESENTATIVE (REP) TO DETERMINE THE CAUSE OF THE SHOCKING. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728536 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1