BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 8733350 · Received June 26, 2019

    Report

    Report Number
    3007566237-2019-01386
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    April 2, 2019
    Report Date
    June 25, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    KOY A, BOCKHORN N, KUHN AA, ET AL. ADVERSE EVENTS ASSOCIATED WITH DEEP BRAIN STIMULATION IN PATIENTS WITH CHILDHOOD-ONSET DYSTONIA. BRAIN STIMULATION 2019. DOI: 10.1016/J.BRS.2019.04.003. COUNTRY OF EVENT: THE LITERATURE ARTICLE NOTED THAT STUDY DATA WAS COLLECTED FROM SITES FROM TWO COUNTRIES: (B)(6); HOWEVER, IT WAS NOT POSSIBLE TO DETERMINE WHICH COUNTRY OCCURRED IN. AGE OR DATE OF BIRTH: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES AND PUBLICATION DATE WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL/LOT #: UNKNOWN, UDI #: ASKU. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN, UDI #: ASKU. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN, UDI #: ASKU. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN, UDI #: ASKU. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN, UDI #: ASKU. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN, UDI #: ASKU. PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL/LOT #: UNKNOWN, UDI #: ASKU. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UDI #: ASKU. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UDI #: ASKU. PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL/LOT #: UNKNOWN, UDI #: ASKU. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UDI #: ASKU. PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL/LOT #: UNKNOWN, UDI #: ASKU. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UDI #: ASKU. PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL/LOT #: UNKNOWN, UDI #: ASKU. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UDI #: ASKU. PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL/LOT #: UNKNOWN, UDI #: ASKU. PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL/LOT #: UNKNOWN, UDI #: ASKU. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UDI #: ASKU. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UDI #: ASKU. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY: DATA ON PEDIATRIC DBS IS STILL LIMITED BECAUSE OF SMALL NUMBERS IN SINGLE CENTER SERIES AND LACK OF SYSTEMATIC MULTI-CENTER TRIALS. THE AUTHORS EVALUATE SHORT- AND LONG-TERM ADVERSE EVENTS (AES) OF PATIENTS UNDERGOING DEEP BRAIN STIMULATION (DBS) DURING CHILDHOOD AND ADOLESCENCE. DATA COLLECTED BY THE GERMAN REGISTRY ON PEDIATRIC DBS (GEPESTIM) WERE ANALYZED ACCORDING TO REVERSIBLE AND IRREVERSIBLE AES AND TIME OF OCCURRENCE WITH RELATION TO DBS-SURGERY: INTRAOPERATIVE, PERIOPERATIVE (<4 WEEKS), POSTOPERATIVE (4 WEEKS < 6 MONTHS) AND LONG TERM AES (>6 MONTHS). 72 PATIENTS WITH CHILDHOOD-ONSET DYSTONIA FROM 10 DBS-CENTERS, WHO RECEIVED 173 DBS ELECTRODES AND 141 IMPLANTABLE PULSE GENERATORS (IPG), WERE INCLUDED IN THE REGISTRY. MEAN TIME OF POSTOPERATIVE FOLLOW-UP WAS 4.6 ± 4 YEARS. IN TOTAL, 184 AES WERE DOCUMENTED IN 53 PATIENTS (73.6%). 52 DBS RELATED AES IN 26 PATIENTS (36.1%) REQUIRED 45 SUBSEQUENT SURGICAL INTERVENTIONS 4.7 ± 4.1 YEARS (RANGE: 3 MONTHS -15 YEARS) AFTER INITIAL IMPLANTATION. THE TOTAL RISK OF AN AE REQUIRING SURGICAL INTERVENTION WAS 7.9% PER ELECTRODE-YEAR. HARDWARE-RELATED AES WERE THE MOST COMMON REASON FOR SURGERY. THERE WAS A TENDENCY OF A HIGHER RATE OF AES IN PATIENTS AGED 7-9 YEARS BEYOND 6 MONTHS AFTER IMPLANTATION. THE INTRAOPERATIVE RISK OF AES IN PEDIATRIC PATIENTS WITH DYSTONIA UNDERGOING DBS IS VERY LOW, WHEREAS THE RATE OF POSTOPERATIVE HARDWARE-RELATED AES IS A PROMINENT FEATURE WITH A HIGHER OCCURRENCE COMPARED TO ADULTS, ESPECIALLY ON LONG-TERM FOLLOW-UP. FACTORS LEADING TO SUCH AES MUST BE IDENTIFIED AND PATIENT MANAGEMENT HAS TO BE FOCUSED ON RISK MINIMIZATION STRATEGIES IN ORDER TO IMPROVE DBS THERAPY AND MAXIMIZE OUTCOME IN PEDIATRIC PATIENTS. REPORTED EVENTS: 12 PATIENTS EXPERIENCED 15 INSTANCES OF IRREVERSIBLE WOUND INFECTION (DEFINED BY AUTHORS AS REQUIRING SURGICAL INTERVENTION). FOUR OF THESE PATIENTS HAD IMPAIRED WOUND HEALING AND INFECTION. TWO INSTANCES OF INFECTION OCCURRED IN THE PERI-OPERATIVE AND EXTENDED INTO THE SHORT TERM INTERVAL, TWO OCCURRED IN THE SHORT-TERM INTERVAL, AND THE OTHER 11 IN THE LONG-TERM INTERVAL. EIGHT OF THESE INSTANCES REQUIRED INS AND/OR EXTENSION REMOVAL/REPLACEMENT, AND SEVEN REQUIRED WHOLE SYSTEM REMOVAL/REPLACEMENT. EXPLANT DUE TO RECURRENT INFECTION WAS PERFORMED ONE YEAR (2 PATIENTS) AND FOUR YEARS (3 PATIENTS) AFTER IMPLANT WITH ONE OF THE FIVE PATIENTS BEING RE-IMPLANTED. ONE PATIENT WITH INTERNAL GLOBUS PALLIDUS DEEP BRAIN STIMULATION (GPI-DBS) EXPERIENCED REVERSIBLE, ASYMPTOMATIC, RIGHT-SIDED INTRACRANIAL HEMORRHAGE IN THE PERI-OPERATIVE INTERVAL (DEFINED AS LESS THAN 4 WEEKS AFTER DBS SURGERY). BLEEDING WAS IDENTIFIED ON POST-OPERATIVE IMAGING TWO DAYS AFTER PALLIDOTOMY AND SUBSEQUENT INCOMPLETE REMOVAL OF LEAD ON THE SAME SIDE AND COMPLETE REMOVAL OF THE LEFT LEAD, ALL WITHIN THE SAME SURGICAL SESSION. TWO PATIENTS EXPERIENCED TECHNICAL DEFECT OF THE LEAD ACCORDING TO HIGH IMPEDANCES ON THE CONNECTING SITES IN THE LONG-TERM INTERVAL WHICH REQUIRED SYSTEM REMOVAL/REPLACEMENT. FOUR PATIENTS EXPERIENCED LEAD DISLOCATION/MIGRATION IN THE LONG-TERM INTERVAL WHICH REQUIRED SYSTEM REMOVAL/REPLACEMENT. ONE PATIENT EXPERIENCED LEAD MALPOSITION IN THE LONG-TERM INTERVAL, WHICH REQUIRED SYSTEM REMOVAL/REPLACEMENT. ONE PATIENT EXPERIENCED EXTENSION TECHNICAL DEFECT INDICATED BY REPEATEDLY MEASURED HIGH IMPEDANCES ON THE CONNECTING SITES IN THE LONG TERM INTERVAL. THE DEVICE WAS REPLACED. ONE PATIENT EXPERIENCED INCREASED SEIZURE FREQUENCY IN THE LONG TERM INTERVAL. THREE PATIENTS EXPERIENCED FOUR INSTANCES OF INS DISLOCATION IN THE LONG-TERM POST-OP INTERVAL WHICH REQUIRED REMOVAL/REPLACEMENT. TWO PATIENTS EXPERIENCED THREE INSTANCES OF EXTENSION LEAD FRACTURE IN THE LONG-TERM POST-OP INTERVAL WHICH REQUIRED REMOVAL/REPLACEMENT. ONE PATIENT EXPERIENCED THREE INSTANCES OF DISCOMFORT/PAIN IN THE LONG-TERM POST-OP INTERVAL WHICH REQUIRED EXTENSION LEAD REVISION AND/OR CHANGE OF INS POSITION. ONE PATIENT EXPERIENCED IRREVERSIBLE SEROMA IN THE SHORT-TERM POST-OPERATIVE PERIOD AND REQUIRED INS AND/OR LEAD EXTENSION REMO VAL/REPLACEMENT. EIGHT PATIENTS EXPERIENCED 11 INSTANCES OF INS TECHNICAL DEFECT, ONE IN THE SHORT-TERM POST-OP INTERVAL AND 7 PATIENTS (10 INSTANCES) IN THE LONG-TERM INTERVAL, WHICH REQUIRED INS REMOVAL/REPLACEMENT. ONE PATIENT EXPERIENCED EXTENSION TECHNICAL DEFECT IN THE SHORT-TERM WHICH REQUIRED REMOVAL/REPLACEMENT. THREE PATIENTS EXPERIENCED EXTENSION DISLOCATION/MIGRATION, ONE IN THE SHORT-TERM AND TWO IN THE LONG TERM POST-OPERATIVE INTERVAL, WHICH REQUIRED REMOVAL/REPLACEMENT. IT WAS SPECIFIED THAT IN ONE PATIENT IT WAS THE RETRO-AURICULAR PART THAT MIGRATED. FIVE PATIENTS EXPERIENCED REVERSIBLE WOUND INFECTION, THREE IN THE SHORT-TERM POST-OPERATIVE INTERVAL AND TWO IN THE LONG-TERM INTERVAL, WHICH DID NOT REQUIRE EXPLANT. SIX PATIENTS EXPERIENCED LACK OR LOSS OF EFFICACY IN THE LONG-TERM INTERVAL WHICH REQUIRED SYSTEM REPLACEMENT/REMOVAL IN FOUR PATIENTS AND INS AND/OR EXTENSION REPLACEMENT/REMOVAL IN TWO PATIENTS. IT WAS NOTED THAT THE PHENOMENON OF DECREASING EFFECT OVER TIME IS MOSTLY ATTRIBUTED TO THE PROGRESSION OF DISEASE IN PATIENTS WITH INHERITED FORMS OF ISOLATED OR NEURODEGENERATIVE DYSTONIA.. ALL PATIENTS WERE IMPLANTED WITH DEEP BRAIN STIMULATION (DBS) FOR EITHER ISOLATED INHERITED AND IDIOPATHIC DYSTONIA, COMBINED INHERITED AND IDIOPATHIC DYSTONIA, OR ACQUIRED DYSTONIA. THE FOLLOWING DEVICE INFORMATION WAS IDENTIFIED IN THE LITERATURE ARTICLE: INS MODELS 37612, 37601, 37602/37603, 7428, 7426.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527770 UNKNOWN IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention