BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 14466003 · Received May 21, 2022

    Report

    Report Number
    2182207-2022-00846
    Event Type
    Injury
    Date Received
    May 21, 2022
    Date of Event
    February 10, 2022
    Report Date
    May 20, 2022
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL/LOT# UNKNOWN. PRODUCT TYPE LEAD PRODUCT ID NEU_INTERSTIM_INS, SERIAL/LOT# UNKNOWN. PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL/LOT# UNKNOWN. PRODUCT TYPE LEAD PRODUCT ID NEU_INTERSTIM_INS, SERIAL/LOT# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. PRODUCT ID: NEU_INTERSTIM_INS, SERIAL/LOT #: UNKNOWN. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. PRODUCT ID: NEU_INTERSTIM_INS, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MARTIN, S., ZILLIOUX, J., GOLDMAN, H. B. IS SACRAL NEUROMODULATION EFFECTIVE IN PATIENTS WITH PARKINSON'S DISEASE? A RETROSPECTIVE REVIEW. NEUROUROL URODYN. DOI: 2022.10.1002/NAU.24900 SUMMARY: PARKINSON'S DISEASE (PD) IS THE SECOND-MOST COMMON DEGENERATIVE NEUROLOGIC DISEASE WORLDWIDE. OVERACTIVE BLADDER (OAB) IS PREVALENT IN THIS POPULATION BUT CAN BE CHALLENGING TO TREAT. SACRAL NEUROMODULATION (SNM) IS AN ATTRACTIVE OPTION BUT REMAINS UNDERSTUDIED. WE HAVE UTILIZED SNM IN PD PATIENTS AND HEREIN DESCRIBE OUR OUTCOMES. WE PERFORMED A RETROSPECTIVE CHART REVIEW OF PD PATIENTS WHO UNDERWENT PERIPHERAL NERVE EVALUATION (PNE) OR STAGE 1 SNM FROM 2000 TO 2020. THE PRIMARY OUTCOME WAS PROGRESSION TO A PERMANENT IMPLANT. THE IMPACT OF PD STAGE AND PREPROCEDURAL URODYNAMIC (UDS) PARAMETERS ON TESTPHASE OUTCOME WERE INVESTIGATED. LONG-TERM EFFICACY WAS ASSESSED USING WILCOXON MATCHED-PAIRS TEST LOOKING AT A CHANGE IN URINARY SYMPTOMS (FREQUENCY, NOCTURIA, INCONTINENCE EPISODES, AND PAD USE) DOCUMENTED AT FOLLOW-UP VISITS AND FURTHER NEED FOR TREATMENT. THIRTY-FOUR PATIENTS UNDERWENT TEST PHASE SNM (7 PNE AND 27 STAGE 1). MEDIAN FOLLOW-UP WAS 11 (INTERQUARTILE RANGE 5.8¿29.8) MONTHS. INDICATIONS INCLUDED REFRACTORY OAB (30/34) AND NONOBSTRUCTIVE URINARY RETENTION (4/34). OVERALL, 82% (28/34) OF PATIENTS PROCEEDED TO A PERMANENT IMPLANT. 71% (5/7) OF PNES WERE SUCCESSFUL. TEST-PHASE SUCCESS DID NOT DIFFER BASED ON PD DISEASE SEVERITY OR UDS PARAMETERS. IN PATIENTS WITH OAB/URGENCY INCONTINENCE WHO PROGRESSED TO THE PERMANENT IMPLANT, THERE WAS A STATISTICALLY SIGNIFICANT IMPROVEMENT IN THEIR URINARY SYMPTOMS FROM BASELINE. MOST (68%) PATIENTS WERE ABLE TO DISCONTINUE OAB MEDICATIONS POST-IMPLANT. THE OVERALL LEAD REVISION RATE WAS 14% (4/28) AND 3 DEVICES REQUIRED REMOVAL. SNM IS AN EFFICACIOUS TREATMENT OPTION FOR PD PATIENTS WITH A HIGH PERCENTAGE OF PATIENTS HAVING IMPROVEMENT IN THEIR URINARY SYMPTOMS. REPORTED EVENTS: 1. OVERALL LEAD REVISION RATE WAS 14% (4/28) AT A MEAN TIME OF 20.5 (RANGE 1¿40) MONTHS AFTER INITIAL DEVICE PLACEMENT. 2. ONE PATIENT EXPERIENCED A LOSS OF TREATMENT AT 44 MONTHS AND HAD THEIR DEVICE REMOVED. 3. ONE PATIENT EXPERIENCED EROSION OF THEIR DEVICE AT 85 MONTHS AFTER THE PATIENT DEVELOPED STIFF (PERSON SYNDROME FROM RHABDOMYOLYSIS WHICH LED TO IMMOBILITY AND LAYING ON THE IPG SITE FOR A PROLONGED TIME) 4. ONE PATIENT EXPERIENCED LEAD TRANSECTION AT 1 MONTH WHEN A LOCAL PROVIDER ATTEMPTED TO REMOVE STITCH AT IMPLANT SITE; HOWEVER, THIS PATIENT WENT ON TO SUBSEQUENT SUCCESSFUL REIMPLANTATION. SEE ATTACHED LITERATURE ARTICLE. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582316 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention