BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 5972646 · Received September 23, 2016

    Report

    Report Number
    3007566237-2016-03351
    Event Type
    Injury
    Date Received
    September 23, 2016
    Date of Event
    July 2, 2016
    Report Date
    September 23, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: PLEASE NOTE THIS DATE IS BASED OFF OF THE ARTICLE¿S PUBLICATION DATE AS THE SPECIFIC EVENT DATE WAS NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENTS WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778, PRODUCT TYPE: LEAD. DEVICE USED FOR OFF LABEL INDICATION. THE INDICATION THE DEVICE WAS USED FOR WAS CLASSICAL TRIGEMINAL NEURALGIA. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    JAKOBS, M., UNTERBERG, A., TREEDE, R.D., SCHUH-HOFER, S., AHMADI, R. SUBCUTANEOUS TRIGEMINAL NERVE FIELD STIMULATION FOR REFRACTORY TRIGEMINAL PAIN: A COHORT ANALYSIS. ACTA NEUROCHIRURGICA. 2016. 158(9):1767-1774. DOI: 10.1007/S00701-016-2881-6. SUMMARY: PATIENTS WERE CLASSIFIED ACCORDING TO THE INTERNATIONAL HEADACHE SOCIETY CLASSIFICATION (ICHD-3-BETA). THREE PATIENTS HAD CLASSICAL TN WITHOUT (N = 3) AND ANOTHER THREE TN WITH CONCOMITANT PERSISTENT FACIAL PAIN (N = 3). TWO PATIENTS SUFFERED FROM POST-HERPETIC TRIGEMINAL NEUROPATHY (N = 2). ALL EIGHT PATIENTS UNDERWENT A TRIAL STIMULATION OF AT LEAST 7 DAYS WITH SUBCUTANEOUS LEADS IN THE AFFECTED TRIGEMINAL AREA CONNECTED TO AN EXTERNAL NEUROSTIMULATOR. OF THOSE, SIX PATIENTS RECEIVED PERMANENT IMPLANTATION OF A NEUROSTIMULATOR. DURING THE FOLLOW-UP (6¿29 MONTHS,MEAN 15.2), VAS-SCORES, ATTACK FREQUENCIES, ORAL DRUG INTAKE, COMPLICATIONS AND SIDE EFFECTS WERE DOCUMENTED. REPORTED EVENTS: A (B)(6) FEMALE CLASSICAL TRIGEMINAL NEURALGIA (TN) PATIENT ¿DEVELOPED A DEVICE INFECTION 4 MONTHS AFTER IMPLANTATION, BOTH AT THE SITE OF THE TEMPORAL ELECTRODE FIXATION AS WELL AS ON THE TIP OF THE SUPRAORBITAL ELECTRODE. THE DEVICE, WHICH HAD TO BE EXPLANTED, WAS CONTAMINATED WITH A STRAIN OF (B)(6). THE PATIENT WAS TREATED ACCORDINGLY WITH ANTIBIOTICS.¿ IT WAS NOTED THAT IMMEDIATELY AFTER DEVICE EXPLANT, THE PATIENT EXPERIENCED A RECURRENCE OF ONGOING BACKGROUND PAIN, WHILE PAIN ATTACHES RECURRED IN THE COURSE OF THE FOLLOWING TWO WEEKS. AS OF THREE MONTHS AFTER ¿TEMPORARY ELECTRODE EXPLANTATION,¿ THE PATIENT HAD EXPERIENCED SAFE WOUND HEALING AND PRESENTED AN ABSENCE OF ANY SIGNS OF INFECTION. THE PATIENT WAS SCHEDULED FOR A SECOND DEVICE IMPLANTATION AT THAT TIME. THE PATIENT EXPERIENCED A PAIN REDUCTION IDENTICAL TO THE FIRST DEVICE IMPLANTATION FOLLOWING IMPLANT OF THE SECOND DEVICE. IT WAS NOTED THAT ¿NO DEVICE FAILURE OCCURRED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624374 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37712 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention