BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2841584 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10607
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 24, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37742, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID (B)(4), LOT # N130238, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY. THE SYSTEM ONLY INCLUDES ONE LEAD, ONE ACCESSORY, AND ONE PROGRAMMER, IN CONTRAST TO THE DUPLICATE PRODUCTS REPORTED IN THE INITIAL REPORT. ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FOUND THAT THE BATTERY CAPACITY WAS REDUCED DUE TO OVERDISCHARGE. IT WAS FURTHER STATED THAT THE INS WAS NEVER RECHARGED UNTIL RECEIVED FOR ANALYSIS ON (B)(4) 2012. ANALYSIS OF THE PLUG FOUND NO ANOMALY. ANALYSIS OF THE LEAD FOUND THAT THE CONDUCTOR BODY WAS BROKEN DUE TO OVERSTRESS/DAMAGE. IT WAS FURTHER STATED THAT ALL CONDUCTORS WERE BROKEN 11.7 CM FROM THE DISTAL END. THE OUTER INSULATION WAS PINCHED 10.3 CM FROM THE DISTAL END (SUSPECTED TOOL MARKS).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3778-60 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 37742 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 37742 LOT# SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3550-29 LOT# N130238, IMPLANTED: 2008 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID, 3550-29 LOT# N130238, IMPLANTED: 2008 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NORMAL BATTERY DEPLETION WAS SEEN DUE TO OVERDISCHARGE FOR 3 TIMES. THE PATIENT HAD LOST OF THERAPEUTIC EFFECT DUE TO OVERDISCHARGE. THE PATIENT HAD A LOT OF PAIN IN POCKET SITE. THE PATIENT WAS UNAWARE THE IMPLANTED BATTERY WAS RECHARGEABLE DEVICE. THE PATIENT SEEN THE MANUFACTURER'S REPRESENTATIVE AND CONFIRMED THE OVERDISCHARGE. THE PATIENT WAS ABLE TO GET THE RECHARGING SCREEN BUT ONLY FOR A SHORT PERIOD OF TIME AND THEN UNABLE TO. THE PATIENT WAS UNABLE TO OBTAIN A RECHARGING SCREEN AFTER 2 CONSECUTIVE PHYSICIAN RESETS. THE PATIENT HAD 3RD PHYSICIAN RESET, THE RECHARGING SCREEN APPEARED. WHEN HER BATTERY WENT INTO OVERDISCHARGE, IT WAS VERY HARD TO GET PROPER CONNECTION. IT WAS UNABLE TO GET MORE THAN 2 BARS FOR CONNECTION DESPITE VARIOUS ATTEMPTS, REPOSITIONING EFFORTS, ADDITION OF SPACERS, ANTENNAE LOCATION, ETC. THE PHYSICIAN AND THE CASE MANAGER WERE ALL MADE AWARE OF FAILED ATTEMPTS IN GETTING BETTER CONNECTION. THE PATIENT WAS INSTRUCTED TO CONTINUE TO TRY AND CHARGE BATTERY DESPITE BAD CONNECTION. THE PATIENT USED DEVICE DAILY AND "NEVER TURNED IF OFF." THE PATIENT FELT THE STIM STOPPED WORKING AT THE MAY/BEGINNING OF JUNE. THE DEVICE SYSTEM WAS EXPLANTED. THE PATIENT STATUS WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention