BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2836317 · Received November 16, 2012

    Report

    Report Number
    3004209178-2012-10408
    Event Type
    Injury
    Date Received
    November 16, 2012
    Report Date
    October 19, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD , PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER, PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT, PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS CHECKED FOR INFECTION, AND SOMETHING (SLUDGE/BACTERIA) WAS PUT ON THE IMPLANTED INS (IMPLANTABLE NEUROSTIMULATOR) BECAUSE THE PATIENT HAD A HIGH RISK OF INFECTION. THE PATIENT WENT TO THE ER ON (B)(6) BECAUSE SHE WAS "LEAKING". THE DOCTOR AT THE ER SAID SHE HAD NOTHING TO WORRY ABOUT BECAUSE HER LEAKING WAS A PROCESS CALLED "WEEPING" AND WAS NATURAL. THE PATIENT KEPT THE IMPLANT SITE BANDAGED UP AND IT STOPPED. IT WAS NOTED THAT THE HCP GAVE THE PATIENT AN IV, CHECKED TO MAKE SURE THERE WAS NO INFECTION, AND PUT THE PATIENT ON AN ANTIBIOTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. PLEASE NOTE THAT THIS HAS ALSO BEEN REPORTED FOR MANUFACTURER REPORT NOS. 3004209178-2012-10386 AND 3004209178-201 2-10389.

    Description of Event or Problem · 1

    FOLLOW UP FROM THE HEALTH CARE PROVIDER (HCP) REPORTED THE PATIENT HAD HAD SEVERAL SURGERIES FOR REVISIONS OF IMPLANTABLE NEUROSTIMULATOR (INS) PLACEMENT, THERE HAS NEVER BEEN ANYTHING WRONG WITH THE DEVICE IT HAD BEEN DUE TO PATIENT PREFERENCE FOR PLACEMENT OF THE DEVICE. THE PATIENT HAS ENCOUNTERED INFECTIONS THAT WERE TREATED WITH ANTIBIOTICS AND TOPICAL SOLUTIONS AS PATIENT WAS ALWAYS CONCERNED ABOUT INFECTION AND ALWAYS HAD PAIN ISSUES AFTER THEIR SURGERIES. THE SEEPING WAS PART OF THE WOUND HEALING AND WAS CONSIDERED NORMAL AT THE TIME. THE PATIENT WAS SEEN BY THE HCP AND THE SITE WAS HEALING NICELY. TWO DAYS LATER THE PATIENT WAS SEEN AGAIN AND THE SITE WAS HEALED AND LOOKED FINE. NO PROBLEMS AT THE TIME. THE PATIENT REPORTED THE DEVICE LOCATED IN THEIR STOMACH WAS NOT ANY MORE COMFORTABLE THAN THEIR BACK AND NOW THEY WOULD LIKE IT MOVED BACK TO THEIR BACK OR A DIFFERENT LOCATION. REVISION WAS SCHEDULED FOR (B)(6) 2012. IT WAS UNKNOWN WHERE THE PATIENT'S DEVICE CURRENTLY WAS AT THE TIME OF REPORT. DURING THE REVISIONS THE HCP ALWAYS WASHED OUT THE BATTERY SITE AND THAT IS WHERE THE HCP FEELS THE PATIENT IS REPORTING THE SLUDGE COMMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention