BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2962194 · Received February 14, 2013

    Report

    Report Number
    3004209178-2013-02658
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 25, 2013
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-45, LOT# V939349, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3487A-45, LOT# V940172, , IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE LAST TIME ANY STIMULATION WAS FELT BY THE PATIENT WAS LESS THAN 1 MONTH PRIOR TO THE REPORT. THE LAST SUCCESSFUL RECHARGING SESSION WAS REPORTED TO BE LESS THAN 1 MONTH AGO. IT WAS STATED THE PATIENT CHARGED IT FOR HOURS. IT WAS STATED THAT THE PATIENT "CHARGED IT ALL THE WAY BUT WASN'T SURE." IT WAS STATED THAT SHE DID USE HER IMPLANTABLE NEUROSTIMULATOR (INS) "A LITTLE MORE THAN SHE DID LAST WEEK." PATIENT PROGRAMMER WAS SHOWING POOR COMMUNICATION. ANTENNA LOCATE (AL) FEATURE WAS USED BUT WAS UNSUCCESSFUL WITH GETTING POWER ON RESET (POR). IT WAS ALSO STATED THAT HER INS WAS STICKING OUT 6 INCHES IN THE POCKET SITE WHEN SHE FIRST GOT HER INS IMPLANTED. THE POCKET SITE DEVELOPED FLUID AND WAS SWOLLEN. THE PATIENT NEVER HAD ANY FURTHER TESTING DONE ON THE POCKET SITE BUT IT WAS STATED THAT "IT WAS OBVIOUS." A FEW DAYS AFTER IMPLANT AT THE VISIT TO HER HEALTHCARE PROFESSIONAL (HCP) IT WAS SAID THAT EVERYTHING LOOKED FINE. THE INS HAD SUBSIDED SINCE THEN BUT THE PATIENT WANTED TO HAVE POCKET SITE CHECKED T O MAKE SURE EVERYTHING WAS WHERE IT SHOULD BE. IT WAS STATED THE PATIENT WAS "STILL PULLING STITCHES OUT." ONE DAY LATER IT WAS DISCOVERED THAT PATIENT'S INS WAS NOT OVER-DISCHARGED AND THE PATIENT LAST FELT HER STIMULATION 2 DAYS AGO AND LAST RECHARGED FIVE DAYS PRIOR. A LOW BATTERY LEVEL WAS ALSO REPORTED. MORE THAN TWO WEEKS LATER IT WAS STATED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. THE INS WAS REPROGRAMMED MULTIPLE TIMES BUT IT DIDN'T HELP. A LITTLE LESS THAN THREE MONTHS LATER IT WAS STATED THAT THE PATIENT STILL HAD CONCERNS BUT WAS WORKING WITH HER HCP/MANUFACTURER REPRESENTATIVE. THE APPOINTMENT DATE WAS NOTED AS (B)(6) 2013. IT WAS ALSO NOTED THAT "THE LEADS WERE BREAKING." IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS BELIEVED THE POCKET WAS DRAINED. THERE WAS NO INFECTION PRESENT AND THAT PATIENT WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64666 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1