BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 7129709 · Received December 19, 2017

    Report

    Report Number
    3004209178-2017-26270
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Report Date
    January 2, 2018
    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
    MO, 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

    ADVERSE EVENT PRODUCT PROBLEM . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THE PATIENT HAD USED THEIR INS FOR A COUPLE YEARS BUT STOPPED USING IT BECAUSE OF A LOSS OF THERAPEUTIC EFFECT. SO THE PATIENT GOT AN INTRATHECAL PUMP DEVICE AND PREFERRED THE PUMP OVER THE INS BECAUSE IT WAS WORKING GREAT AT RELIEVING THE PATIENT'S PAIN SO THE PATIENT QUIT USING AND CHARGING THEIR INS. THE DOCTOR REPORTED THE PATIENT HAD NOT USED THEIR INS IN YEARS. IT WAS REPORTED THEY DO NOT KNOW FOR SURE IF THE INS HAS REACHED "END OF LIFE"; THEY HAVE NOT SEEN AN EOL ERROR CODE. THE REP AND THE DOCTOR WERE ASSUMING THE INS HAD DIED BASED OFF OF THE IMPLANT DATE OF (B)(6) 2008. IT WAS UNKNOWN HOW MANY TIMES THE PATIENT'S INS HAD GONE INTO OVERDISCHARGE; THERE IS RECORD OF IT GOING INTO OVERDISCHARGE AT LEAST TWO TIMES. NO STEPS HAVE BEEN TAKEN TO ADDRESS THE DEAD INS. THE PATIENT HAS NOT SEEN THE DOCTOR FOR THEIR INS SINCE (B)(6) 2017 AND THE DOCTOR HAS NO PLAN TO REPLACE THE PATIENT'S INS. IT WAS NOTED THE PATIENT DOES SEE THE SAME DOCTOR FOR THEIR PAIN PUMP. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THE PATIENT HAD USED THEIR INS FOR A COUPLE YEARS BUT STOPPED USING IT BECAUSE OF A LOSS OF THERAPEUTIC EFFECT. SO THE PATIENT GOT AN INTRATHECAL PUMP DEVICE AND PREFERRED THE PUMP OVER THE INS BECAUSE IT WAS WORKING GREAT AT RELIEVING THE PATIENT'S PAIN SO THE PATIENT QUIT USING AND CHARGING THEIR INS. THE DOCTOR REPORTED THE PATIENT HAD NOT USED THEIR INS IN YEARS. IT WAS REPORTED THEY DO NOT KNOW FOR SURE IF THE INS HAS REACHED "END OF LIFE"; THEY HAVE NOT SEEN AN EOL ERROR CODE. THE REP AND THE DOCTOR WERE ASSUMING THE INS HAD DIED BASED OFF OF THE IMPLANT DATE OF (B)(4) 2008. IT WAS UNKNOWN HOW MANY TIMES THE PATIENT'S INS HAD GONE INTO OVERDISCHARGE; THERE IS RECORD OF IT GOING INTO OVERDISCHARGE AT LEAST TWO TIMES. NO STEPS HAVE BEEN TAKEN TO ADDRESS THE DEAD INS. THE PATIENT HAS NOT SEEN THE DOCTOR FOR THEIR INS SINCE (B)(6) 2017 AND THE DOCTOR HAS NO PLAN TO REPLACE THE PATIENT'S INS. IT WAS NOTED THE PATIENT DOES SEE THE SAME DOCTOR FOR THEIR PAIN PUMP. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT VIA MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WAS IN AN OVERDISCHARGED STATE AND THEY WERE UNABLE TO CHARGE THE BATTERY. THE PATIENT MENTIONED THAT THEY WERE INVOLVED IN A MOTOR VEHICLE ACCIDENT ABOUT TWO YEARS PRIOR TO THE DATE OF THIS REPORT. THE PATIENT STATED THAT THEY LOST THEIR RECHARGER AT THAT TIME; WITH REHAB AND OTHER ACTIVITIES RECOVERING FROM THE ACCIDENT, THEY DIDN¿T GET TO ADDRESS THEIR INS. IT WAS NOTED THAT THE OVERDISCHARGE WAS VERIFIED USING A CLINICIAN PROGRAMMER 8840. THE PATIENT STATED THAT THEY WERE EDUCATED IN THE PHYSICIAN MODE RESET (PMR) METHOD AND THAT THEY WOULD COMPLETE IT AT HOME. THE PATIENT WAS TO CALL WHEN THEY WERE FINISHED AND IF THEY WERE ABLE TO GET THE POWER ON RESET (POR) SCREEN OR NOT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT HADN¿T ATTEMPTED TO COMPLETE THE PMR OR POR. THE ISSUE HAD NOT YET BEEN RESOLVED. NO PATIENT SYMPTOMS WERE REPORTED AND THERE WERE NO COMPLICATIONS. THE PATIENT¿S STATUS AT THE TIME OF THIS REPORT IS ¿ALIVE, NO INJURY.¿ INDICATION FOR USE IS FAILED BACK SURGERY SYNDROME. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2017, FROM A HEALTHCARE PROVIDER (HCP) REPORTING THAT THE PATIENT TOLD THEM THEIR INS HAD BEEN DEAD FOR OVER A YEAR. THE HCP STATED THAT THE PATIENT WAS GIVEN A KIT TO MAKE THEIR INS WORK AGAIN, BUT THIS DIDN¿T RESOLVE THE ISSUE. THE PATIENT HAD BEEN TOLD THAT THEIR INS NEEDED TO BE REPLACED. AN OVERDISCHARGE EVENT WAS REPORTED. NO SYMPTOMS WERE REPORTED. IT WAS ASKED BUT UNKNOWN WHEN THE EVENT OCCURRED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910662 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1