BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2518109 · Received April 5, 2012

    Report

    Report Number
    3004209178-2012-02136
    Event Type
    Injury
    Date Received
    April 5, 2012
    Report Date
    March 12, 2012
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3998, LOT #V157497, IMPLANTED: (B)(6) 2009; LEAD MODEL 3998, LOT #V082162, IMPLANTED: (B)(6) 2009; EXTENSION MODEL 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, EXTENSION MODEL 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009; EXTENSION MODEL 37082, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009; EXTENSION MODEL 37082, SERIAL #(B)(4), IMPLANTED: (B)(6) 2009; PROGRAMMER MODEL 37743, SERIAL # (B)(4); RECHARGER MODEL 37752, SERIAL # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED FOLLOWING THE IMPLANT SURGERY, THE PATIENT HAD "SIGNIFICANT" PAIN FROM THE SURGICAL INCISIONS. THE PATIENT ONLY HAD IBUPROFEN TO RELIEVE THE PAIN, SO THE PATIENT TOOK SOME PAIN MEDICATION FROM AN UNRELATED SURGERY. FOR THE NEXT SEVERAL WEEKS, THE PATIENT'S PAIN CONTINUED AND THE PATIENT HAD A MARKED LOSS OF MOBILITY AND STIFFNESS IN HIS NECK. WITHIN 5 HOURS OF THE IMPLANT SURGERY, THE PATIENT ALSO HAD HIS FIRST CLUSTER HEADACHE WITH NO RELIEF FROM THE DEVICE. OVER THE NEXT 6 MONTHS, THE DEVICE SETTINGS WERE ADJUSTED AND REPROGRAMMED MULTIPLE TIMES BUT THE PATIENT STILL DID NOT RECEIVE THERAPEUTIC EFFECT. THE PATIENT WANTED THE DEVICE REMOVED SO THAT AT THE LEAST, HE WOULD NOT HAVE TO BE FRISKED WHEN GOING THROUGH THE METAL DETECTOR AT THE AIRPORT DUE TO THE DEVICE SETTING THE DETECTOR OFF. THE PATIENT WANTED A DIFFERENT DOCTOR TO EXPLANT THE DEVICE THOUGH, BUT HE WAS HAVING DIFFICULTY FINDING A NEW DOCTOR. TWO YEARS AFTER IMPLANT, WHILE THE PATIENT WAS TRYING TO FIND A NEW DOCTOR, THE BACK OF THE PATIENT'S HEAD BECAME SWOLLEN AND PAINFUL. THE PATIENT WENT TO HIS ORIGINAL DOCTOR AND IT WAS DISCOVERED A PLASTIC STITCH FROM THE DEVICE SURGERY HAD "WORKED ITS WAY OUT THROUGH THE SKIN." THE AREA WAS OOZING A CLEAR LIQUID THAT WOULD FORM A SCAB, AND EVERY TIME THE PATIENT BATHED, THE WOUND WOULD OPEN UP AGAIN. THE PATIENT WAS PRESCRIBED ANTIBIOTICS TO REDUCE THE SWELLING AND PAIN, AND THE REPORTER STATED THE ORIGINAL DOCTOR AGREED THE DEVICE SHOULD BE EXPLANTED AFTER EXAMINING THE STITCH. THE ENTIRE DEVICE SYSTEM WAS ULTIMATELY EXPLANTED AND THE PATIENT "RECOVERED." AFTER THE SURGERY, THE PATIENT WAS PLEASED TO HAVE THE DEVICE EXPLANTED, BUT HE DID NOT LIKE THE "HORRIBLE" SCARS THAT REMAINED AS A RESULT OF THE DEVICE BEING IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention