BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 6648710 · Received June 16, 2017

    Report

    Report Number
    3004209178-2017-13102
    Event Type
    Malfunction
    Date Received
    June 16, 2017
    Date of Event
    June 4, 2017
    Report Date
    August 2, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    UDI-DI
    00613994610430
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37761, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: PNMA01411A004, LOT# UNKNOWN, PRODUCT TYPE: RECHARGER. 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

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THAT THEY HAD PROBLEMS WITH THEIR "NIKS WITH CB-CD." THEY INDICATED THAT THEIR INABILITY TO CONNECT WITH THEIR INS HAD BEEN RESOLVED. THEY COULD NOT REMEMBER WHAT THEIR WEIGHT WAS AT THE TIME OF THE EVENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR COMPLEX REG PAIN SYNDROME TYPE II AND SPINAL PAIN. THE PATIENT REPORTED THAT THE CONNECTOR PIN WAS BROKEN/BENT/LOOSE. IT WAS REPORTED THAT THE ADAPTOR CONNECTOR WAS LOOSE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON (B)(6) 2017. THE PATIENT REPORTED THAT SHE RECEIVED THE REPLACEMENT DESKTOP CHARGER AND WAS STILL HAVING THE SAME ISSUE. THE PATIENT REPORTED THAT SHE DEFINITELY THOUGHT THE ISSUE WAS WITH THE RECHARGER AND NOT THE DESKTOP CHARGER. THE PATIENT CONFIRMED THAT THE REPLACEMENT DESKTOP CHARGER DIDN'T RESOLVE THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON (B)(6) 2017. THE PATIENT REPORTED THAT SHE WAS GETTING THE REPOSITION ANTENNA AND IT WASN'T WORKING. THE PATIENT REPORTED THAT SHE WAS IN BED. THE PATIENT REPORTED THAT SHE WAS GETTING POOR COMMUNICATION WITH HER PROGRAMMER AS WELL. THE PATIENT REPORTED THAT ONE MONTH AGO THERAPY WAS WORKING PERFECT UNTIL 1.5 WEEKS PRIOR TO THE REPORT. THE PATIENT ALSO REPORTED GETTING AN EPIDURAL 2 MONTHS PRIOR AND REPORTED THAT THEIR NECK WAS CRUSHED FROM THE NEEDLE. THE PATIENT REPORTED THAT WHEN THE EPIDURAL WAS DONE, PUT MACHINE TO USE MACHINE AND SOMETHING HAPPENED AND TWO HAND STARTED WORKING AND BEFORE THEY DIDN'T WORK. THE PATIENT REPORTED GETTING NO CONNECTION WITH EITHER PROGRAMMER AND CHARGER. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427502 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714 00613994610430

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR