BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3193262 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-10973
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    June 4, 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
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE BATTERY WOULD BE REPLACED FOUR DAYS AFTER THE REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LEAD/EXTENSION WAS NOT COMING OFF OF THE LEFT SIDE AND THE INS APPEARED TO BE FLIPPED BASED ON AN X-RAY OF AN ANTERIOR VIEW. IT WAS NOTED THAT THE PATIENT COULD NEVER GET MORE THAN 1-2 BOXES NO MATTER WHAT THEY DID. ONE WEEK LATER IT WAS REPORTED THAT THE PATIENT WAS DOING GREAT. IT WAS NOTED THAT THE PATIENT WAS GETTING BETTER COVERAGE THAN BEFORE SO HE WAS VERY HAPPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN INITIALLY TOLD IT WOULD ONLY TAKE AN HOUR OR TWO A WEEK TO CHARGE UP THE INS (IMPLANTABLE NEUROSTIMULATOR) USING INSR (INS RECHARGER). IT WAS STATED THAT THE PATIENT WAS A THINNER GUY WHO ONLY WEIGHED (B)(6). IT WAS STATED THAT THE PATIENT HAD BEEN TOLD THE INS MIGHT BE TOO DEEP, BUT THE PATIENT DIDN'T SEE HOW THAT COULD BE SINCE HE WAS THIN. IT WAS STATED THE BEST HE COULD EVER GET WAS TWO COUPLING BARS AND AT THE TIME OF THE REPORT THE UNIT WAS "BORDERLINE DEAD." IT WAS STATED THAT, WHEN HE HAD MET WITH THE MANUFACTURER REPRESENTATIVE, A LOT OF THINGS WERE DONE (REPOSITIONING, ANTENNA LOCATE, CHANGING THE ANTENNA OUT) AND THAT STILL DIDN'T RESOLVE THE ISSUE. IT WAS STATED THE PATIENT WAS TOLD "THIS WAS JUST THE WAY IT WAS (NORMAL) AND IT WASN'T NORMAL BECAUSE HE KNEW OTHER PEOPLE WHO HAD THE UNIT AND THAT WAS THE REASON HE GOT IT." A COUPLING PROBLEM WAS REPORTED. IT WAS STATED THAT DURING THE REPORT THE PATIENT HAD THE RECHARGER ON AND HAD TWO COUPLING BARS, DIDN'T MOVE AND LOST THE SIGNAL. IT WAS STATED THAT "THE SCREEN JUST FLASHED CHANGED SCREENS AND THEN WENT BLANK." THE INS WAS IN HIS RIGHT TOP BUTTOCK AREA. THE RECHARGING ISSUE OCCURRED FOLLOWING AN IMPLANT. TWO DAYS LATER IT WAS REPORTED THAT THE PATIENT WAS HAVING "MAJOR PROBLEMS WITH RECHARGING." IT WAS STATED THAT THE PATIENT WAS EDUCATED AND DOING EVERYTHING RIGHT AND THAT IT WAS DIFFICULT FOR THE PATIENT TO GET 2 BOXES SHADED AND STIMULATOR WAS "GOING OFF A LOT." IT WAS STATED THAT THE PATIENT HAD TO WEAR INSR ALMOST 100% OF THE TIME AND THIS WAS CAUSING THE SITE TO BE SORE. CHARGING WITH AND WITHOUT THE BELT, DIAL ADJUSTMENTS AND HAVING THE PATIENT IN DIFFERENT POSITIONS WERE TRIED BUT THESE EFFORTS DID NOT IMPROVE COUPLING. IT WAS STATED THAT THE PATIENT WAS SLENDER AND FIT, THE INS DID NOT FEEL TOO DEEP OR TILTED AND ONE COULD SEE THE IMPRESSION OF THE INS. THE PATIENT WAS USING SPACERS TO MAKE IT MORE COMFORTABLE FOR HIMSELF. THE INS POCKET WAS TIGHT AND THERE WAS NOT A LOT OF MOVEMENT IN POCKET. NO CHANGES IN THE POCKET WERE REPORTED. LESS THAN TWO WEEKS LATER IT WAS REPORTED THAT X-RAY HAD CONFIRMED THE DEVICE WAS FLIPPED. THE PATIENT WAS WORKING ON SCHEDULING REVISION WITH THE IMPLANTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294608 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 00050 YR Required Intervention