BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2864211 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-11383
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 14, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3998, LOT # V157497, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3998, LOT # V157497, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED STIMULATION HAD BEEN INTERMITTENT. REPRESENTATIVE CHECKED IMPEDANCES AND ONLY 4 ELECTRODES WERE OK THE REST WERE GREATER THAN 10000 OHMS. IMPEDANCES WERE RE-RUN WITH THE PATIENT PUSHING ON THE IMPLANTABLE NEUROSTIMULATOR (INS) AND MORE ELECTRODES WERE "GOOD." APPEARED TO BE INTERMITTENT CONNECTION ISSUE AT INS. POSSIBLE REVISION REQUIRED. FOLLOW UP REPORTED WITHOUT PRESSURE OVER THE BATTERY POCKET 12 ELECTRODES WERE OUT OF RANGE. WITH PRESSURE OVER THE BATTERY POCKET APPROXIMATELY 10 ELECTRODES WERE OUT OF RANGE. IT WAS SUSPECTED THE PROBLEM WAS POOR CONNECTION AT THE BATTERY SITE. PATIENT HAD PLANNED TO SEE THE HEALTH CARE PROVIDER THE FOLLOWING WEEK TO DISCUSS SURGICAL CORRECTION. PATIENT STILL HAD INTERMITTENT THERAPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD A SURGICAL CONSULTATION ON (B)(6), HOWEVER, THE APPOINTMENT WAS CANCELLED. IT WAS STATED THAT IT WAS EXPECTED FOR THE PATIENT TO HAVE SURGERY TO DISCONNECT AND RECONNECT THE LEADS. IT WAS NOTED THE MANUFACTURER REPRESENTATIVE WOULD FOLLOW UP THEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE PATIENT'S SURGERY WAS SCHEDULED FOR EITHER (B)(6) 2013. IT WAS INDICATED THAT THE MANUFACTURER'S REPRESENTATIVE WOULD FOLLOW-UP AFTER THAT.

    Description of Event or Problem · 1

    THE PATIENT HAS BEEN RESCHEDULED MULTIPLE TIMES DUE TO INFECTION OF NON-DEVICE RELATED REASONS. THE PATIENT WAS NOT ON THE SCHEDULE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention