BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4386472 · Received January 6, 2015

    Report

    Report Number
    3007566237-2015-00029
    Event Type
    Injury
    Date Received
    January 6, 2015
    Report Date
    December 11, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    AGE: 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. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED 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 NEU_UNKNOWN_EXT, LOT# UNKNOWN, PRODUCT TYPE: EXTENSION; PRODUCT ID 3387, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_EXT, LOT# UNKNOWN, PRODUCT TYPE: EXTENSION; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_EXT, LOT# UNKNOWN, PRODUCT TYPE: EXTENSION; PRODUCT ID 3387, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    CHUNG M, HAN I, CHUNG SS, JANG DK, HUH R. EFFECTIVENESS OF SELECTIVE PERIPHERAL DENERVATION IN COMBINATION WITH PALLIDAL DEEP BRAIN STIMULATION FOR THE TREATMENT OF CERVICAL DYSTONIA. ACTA NEUROCHIRURGICA. 2014. DOI 10.1007/S00701-014-2291-6. SUMMARY: SELECTIVE PERIPHERAL DENERVATION (SPD) AND DEEP BRAIN STIMULATION OF THE GLOBUS PALLIDUS (GPI-DBS) ARE AVAILABLE SURGICAL OPTIONS FOR PATIENTS WITH MEDICALLY REFRACTORY CERVICAL DYSTONIA (CD). THERE ARE FEW DATA AVAILABLE CONCERNING WHETHER PATIENTS WHO HAVE UNSATISFACTORY TREATMENT EFFECTS AFTER PRIMARY SURGERY BENEFIT FROM A DIFFERENT TYPE OF SUBSEQUENT SURGERY. THE AIM OF THIS STUDY WAS TO ASSESS WHETHER COMBINING THESE SURGICAL PROCEDURES (SPD PLUS GPI- DBS) WAS EFFECTIVE IN PATIENTS WITH UNSATISFACTORY TREATMENT EFFECTS AFTER THEIR INITIAL SURGERY. FORTY-ONE PATIENTS WITH MEDICALLY REFRACTORY IDIOPATHIC CD UNDERWENT SPD AND/OR GPI-DBS. PATIENTS WHO WERE DISSATISFIED WITH THEIR PRIMARY SURGERY (SPD OR GPI DBS) ELECTED TO SUBSEQUENTLY UNDERGO A DIFFERENT TYPE OF SURGERY. THESE PATIENTS WERE ASSESSED WITH THE TORONTO WESTERN SPASMODIC TORTICOLLIS RATING SCALE (TWSTRS). SPD ALONE AND GPI-DBS ALONE WERE PERFORMED IN 16 AND 21 PATIENTS, RESPECTIVELY. FOUR PATIENTS HAD UNSATISFACTORY TREATMENT EFFECTS AFTER THE INITIAL SURGERY AND SUBSEQUENTLY UNDERWENT ANOTHER TYPE OF SURGERY. AMONG THEM, TWO PATIENTS WITH PERSISTENT DYSTONIA AFTER SPD SUBSEQUENTLY UNDERWENT GPI-DBS, AND TWO OTHER PATIENTS WHO HAD INSUFFICIENT TREATMENT EFFECTS FOLLOWING GPI-DBS WERE SUBSEQUENTLY TREATED WITH SPD. ALL OF THESE PATIENTS EXPERIENCED SUSTAINED IMPROVEMENT FROM THE COMBINED SURGICAL PROCEDURES ACCORDING TO THE TWSTRS SCORE DURING A LONG-TERM FOLLOW-UP OF 12¿ 90 MONTHS. PATIENTS WITH UNSATISFACTORY TREATMENT EFFECTS AFTER AN SPD OR GPI-DBS EXPERIENCED IMPROVEMENT FROM SUBSEQUENTLY UNDERGOING OTHER TYPES OF SURGERY. THEREFORE, COMBINED SURGICAL PROCEDURES ARE ADDITIONAL SURGICAL OPTIONS WITH GOOD OUTCOMES IN THE TREATMENT OF PATIENTS WITH RESIDUAL SYMPTOMS AFTER THEIR INITIAL SURGERY. REPORTED EVENTS: 1. 1 PATIENT EXPERIENCED HARDWARE-RELATED WOUND PROBLEMS, WHICH SUBSIDED AFTER AN EXTENSION LINE REVISION OPERATION. IT WAS NOTED THAT THIS SUBSIDED WITHOUT PERMANENT SEQUELAE. 2. 1 PATIENT WITH GLOBUS PALLIDUS INTERNUS (GPI) DEEP BRAIN STIMULATION (DBS) EXPERIENCED AN INTRACRANIAL HEMORRHAGE. IT WAS NOTED TO BE A MINIMAL AMOUNT OF SUBDURAL HEMORRHAGE THAT RESOLVED 2 WEEKS AFTER SURGERY. IT WAS NOTED THAT THIS SUBSIDED WITHOUT PERMANENT SEQUELAE. 3. 1 PATIENT EXPERIENCED HARDWARE-RELATED WOUND PROBLEMS, WHICH SUBSIDED AFTER ORAL ANTIBIOTICS. IT WAS NOTED THAT THIS SUBSIDED WITHOUT PERMANENT SEQUELAE. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: LEAD MODEL 3387 AND IMPLANTABLE NEUROSTIMULATORS SOLETRA MODEL 7426 OR ACTIVA MODEL 37603 FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE REPORTED EVENTS. IT WAS REPORTED THAT THE EVENTS INVOLVED ONE (B)(6) MALE, ONE (B)(6) FEMALE, AND ONE (B)(6) FEMALE; THERE WAS NO INFORMATION TO SPECIFY WHICH OF THE EVENTS INVOLVED THESE PATIENTS. FOR EVENT 1 AND EVENT 3, ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PROBLEMS WERE LOCATED IN THE AREAS WHERE THE PATIENTS FELT DISCOMFORT CAUSING FRICTION UNDER THE SKIN. THIS IN TURN WAS RESPONSIBLE FOR INTERNAL INFECTIONS AROUND THE AREA OF THE CONNECTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6190 UNKNOWN IMPLANTABLE NEUROSTIMULATOR IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention