BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3303016 · Received August 22, 2013

    Report

    Report Number
    3004209178-2013-14992
    Event Type
    Malfunction
    Date Received
    August 22, 2013
    Date of Event
    August 3, 2012
    Report Date
    October 29, 2018
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR OFF LABEL INDICATION. THE INDICATION DEVICE USED FOR WAS VULVODYNIA. PRODUCT ID: 37744, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3550-39, LOT# N293790, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3888-33, LOT# V817204, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-33, LOT# V741237, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 355531, LOT# N335418, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: SCREENING DEVICE. PRODUCT ID: 3550-14, LOT# N340395, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3550-14, LOT# N340395, IMPLANTED: (B)(6) 2012 PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3487A-28, LOT# V492276, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVIEW INDICATED THAT NO SERIOUS INJURY HAS OCCURRED AS A RESULT OF THIS EVENT. THEREFORE, WAS CORRECTED TO A MALFUNCTION. 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.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS HAVING COUPLING AND/OR COMMUNICATION ISSUES. THE PATIENT COULDN¿T ¿MOVE AN INCH¿ OTHERWISE SHE LOST HER COUPLING BARS. THE PATIENT THOUGHT THE DEVICE WAS EXTREMELY COMPLICATED, AND THE MANUAL WAS LONG AND COMPLICATED AND EVERYTHING SHOULD HAVE BEEN ¿MUCH SIMPLER¿. APPROXIMATELY, A MONTH LATER, IT WAS REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING DEVICE OR THERAPY BUT WAS WORKING WITH HER HEALTHCARE PROVIDER (HCP) OR MANUFACTURER¿S REPRESENTATIVE. AN APPOINTMENT DATE OF (B)(6) 2012 WAS NOTED. THE REPORTER INDICATED THAT THE DEVICE WAS MAKING THE PATIENT¿S PROBLEM ¿WORSE¿ AND SO THE PATIENT ¿WAS MOST LIKELY GOING TO HAVE IT REMOVED¿. THE FOLLOWING MONTH, IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT AND EXPERIENCED SYMPTOMS OF ACUTE PAIN. THE PATIENT REPORTEDLY GOT SOME RELIEF WITH THE TRIAL BUT ONCE THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED, SHE HAD NOT HAD RELIEF. THE PATIENT¿S DEVICE WAS IMPLANTED FOR VULVODYNIA. THE REPORTER INDICATED THAT WHEN THE PATIENT¿S DEVICE WAS IMPLANTED, IT WAS PLACED ¿FACING DOWN, RETROGRADE¿. AFTER ABOUT A MONTH OR 6 WEEKS AFTER THE INS WAS IMPLANTED, THE PATIENT ¿ALMOST FELT AN INCREASE IN PAIN¿. THE PATIENT FELT THAT THERAPY MIGHT HAVE BEEN MAKING HER SYMPTOMS WORSE. THE PATIENT HAD REPORTEDLY NOT USED STIMULATION SINCE THE PREVIOUS MONTH AND WAS CONCERNED BECAUSE HER IMPLANTABLE NEUROSTIMULATOR (INS) WAS COMPLETELY DEAD. THE PATIENT WAS STILL FEELING STIMULATION. THE PATIENT WAS HOWEVER IN ¿SO MUCH PAIN¿ THAT SHE WANTED TO TRY STIMULATION AGAIN. THE PATIENT¿S HCP ATTEMPTED GIVING HER A NERVE BLOCK ABOUT 2.5 WEEKS PRIOR TO THE REPORT BUT IT ¿DID NOTHING FOR THE PAIN¿. THE REPORTER NOTED THAT THE PATIENT WAS STILL GETTING 0 COUPLING BARS. WHEN THE PATIENT DID GET COUPLING, SHE COULDN¿T MOVE OR SHE LOST IT. THE PATIENT WAS HOWEVER ABLE TO GET ALL 8 COUPLING BARS AT THE TIME OF THE REPORT. IT WAS NOTED THAT THE PATIENT¿S HCP IMPLANTED ¿A 4 PROLONGED LEAD RATHER THAN AN 8 PROLONGED LEAD¿. APPROXIMATELY NINE MONTHS LATER, IT WAS REPORTED THAT THE DEVICE WAS A ¿COMPLETE WASTE OF THE PATIENT¿S TIME¿. THE PATIENT HAD BEEN INFORMED THAT THE DEVICE WAS IMPLANTED IMPROPERLY AND WOULDN¿T HAVE BEEN RECOMMENDED AS A TREATMENT OPTION FOR THE PATIENT¿S ¿PARTICULAR PROBLEM¿. THE DEVICE WAS REPORTEDLY CAUSING THE PATIENT MORE PAIN AS SHE WAS COMPLETELY BEDRIDDEN AND FELT LIKE SHE WAS ¿LYING ON A ROCK ALL THE TIME.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON (B)(4) 2018. THE PATIENT WAS CALLING TO GET AN HEALTHCARE PROFESSIONAL (HCP) LISTINGS BECAUSE THEIR INS IS USELESS. THE CALLER STATED THAT THE SURGERY WAS DONE WRONG AND THE INS WAS PUT IN WRONG- IT WAS JUST A COMPLETE DISASTER. THE PATIENT HAS SEEN MANY DOCTORS WHO HAVE CONFIRMED THAT THE INS WAS NOT PUT IN CORRECTLY. THE INS NOW IS REALLY HURTING THEM AND THEY WANT IT REMOVED. THE ISSUE HAS BEEN SINCE IMPLANT. THE PATIENT ALSO NOTED THAT THEIR MANUFACTURE REPRESENTATIVE (REP) WAS USELESS BECAUSE THEY DID NOT TEACH THEM HOW TO USE THE INS AND FORGOT TO BRING THE CONTROLLER THING FOR THEM TO USE AFTER SURGERY. NO FURTHER COMPLICATIONS WERE REPORTED/ARE ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. IT WAS REPORTED THAT THE PATIENT'S INSURANCE WOULD NOT COVER THE REMOVAL OF THE INS, SO IT IS STILL IMPLANTED IN THEIR BODY. THE PATIENT NOTED THAT THEY ARE STILL IN PAIN. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408023 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other