BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3153601 · Received June 8, 2013

    Report

    Report Number
    3004209178-2013-08925
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    May 17, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (SN# (B)(4)) FOUND NO SIGNIFICANT ANOMALY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PATIENT STATED THEIR STIMULATION FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS) ¿CUTS OUT APPROXIMATELY THREE TIMES A WEEK FOR ONE MINUTE INTERVALS¿ AND WAS NOT RELATED TO THE TYPE OR LENGTH OF TIME OF THEIR BODY POSITION. THE PATIENT REQUESTED THAT THE INS BE REPLACED WITH A RECHARGEABLE MODEL. THE PATIENT WAS SCHEDULED FOR REPLACEMENT SURGERY ON (B)(6) 2013. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE WITH NO INJURY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT¿S STIMULATION WAS ¿SHORTING ON AND OFF¿ INTERMITTENTLY. THE INS AND LEAD CONNECTION WERE CHECKED AND FOUND TO BE OKAY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT WAS SCHEDULED FOR A BATTERY CHANGE ON (B)(6) 2013, BUT THE CASE WAS CANCELLED AND WILL BE RESCHEDULED IN THE NEAR FUTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED STIMULATION WAS INTERMITTENT. IT WAS NOTED THIS HAPPENED WHEN THE PATIENT WAS LYING ON THEIR BACK. IT USUALLY CHANGED TO MORE INTENSE STIMULATION. IT WAS NOTED IT ALSO SOMETIMES HAPPENED WHEN THE PATIENT WAS RECLINING. THE POSITION WAS CHECKED AND WAS IN THE TRANSITION ZONE INSTEAD OF THE UPRIGHT POSITION. IT WAS UNCLEAR IF REORIENTATION TOOK PLACE AFTER THE REVISION. THE PATIENT ALSO NOTED A FADING SENSATION. THE PATIENT SOMETIMES LOSES STIMULATION ALL TOGETHER IN DIFFERENT POSITIONS. PATIENT LOSES STIMULATION WHEN LYING ON THEIR BACK WITH KNEES BENT AND MOVING KNEES TO THE RIGHT AND ALSO WHEN SITTING AND CROSSING LEGS. IT WAS ALSO NOTED THE PATIENT COULD GET THE STIMULATION TO BE STRONGER OR WEAKER BY PUSHING ON THE STIMULATOR. CURRENT IMPEDANCE MEASUREMENTS WERE NORMAL. IMPEDANCES WERE MEASURED AT DIFFERENT POSITIONS AND WERE WITH IN NORMAL RANGE. IT WAS REPORTED THE PATIENT FELT LIKE THEIR DEVICE WAS TURNING ON AND OFF. IT WAS NOTED THE REPRESENTATIVE REORIENTED THE PATIENT THE DAY OF REPORT. IT WAS NOTED THE PATIENT WAS STILL UNHAPPY WITH THEIR STIMULATION. THE PATIENT WAS REPROGRAMMED AND WILL FOLLOW UP WITH THEIR PHYSICIAN AS THEY SEE FIT. THE PATIENT WAS REPORTING ONLY 25% RELIEF AND IS CONTEMPLATING HAVING THE SYSTEM REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE INS WAS REPLACED DUE TO LOSING ORIENTATION ALL THE TIME. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE INS WAS EXPLANTED DUE TO A SHOCKING SENSATION.

    Description of Event or Problem · 1

    PRIOR TO DEVICE REVISION, ADDITIONAL INFORMATION REPORTED THAT THE POCKET SITE WAS "STILL PRETTY TENDER." IT WAS FURTHER NOTED THAT WHEN THE PATIENT WAS SITTING AND CROSSED HER LEGS, SHE WOULD LOSE STIMULATION. IT WAS ALSO NOTED THAT WHEN THE PATIENT WAS LYING DOWN, THE STIMULATION WOULD GO FROM "NOTHING TO LIKE WAY TOO STRONG AND SHE HASN'T EVEN MOVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258643 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