BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3142438 · Received June 3, 2013

    Report

    Report Number
    3007566237-2013-01827
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    November 19, 2012
    Report Date
    May 6, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. PRODUCT ID: NEU_INTERSTIM_INS, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INTERSTIM_INS, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID: NEU_INTERSTIM_INS, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INTERSTIM_INS, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INTERSTIM_INS, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INTERSTIM_INS, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INTERSTIM_INS, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INTERSTIM_INS, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_ENS_STIMULATOR, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: EXTERNAL NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INTERSTIM_INS, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INTERSTIM_INS, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    PETERS, K. M., KANDAGATLA, P., KILLINGER, K. A., WOLFERT, C., BOURA, J. A. CLINICAL OUTCOMES OF SACRAL NEUROMODULATION IN PATIENTS WITH NEUROLOGIC CONDITIONS. UROLOGY. 2013;81(4):738-743. DOI: 10.1016/J.UROLOGY.2012.11.073. SUMMARY: THE OBJECTIVE WAS TO EXAMINE THE OUTCOMES IN PATIENTS WITH AND WITHOUT A COMORBID NEUROLOGIC DIAGNOSIS (ND) OR NEUROGENIC BLADDER DYSFUNCTION AFTER A STAGED NEUROMODULATION PROCEDURE FOR REFRACTORY BLADDER SYMPTOMS. PATIENTS ENROLLED IN OUR PROSPECTIVE NEUROMODULATION DATABASE STUDY WERE GROUPED ACCORDING TO THE PRESENCE OF A COEXISTING ND. THE IMPLANTABLE PULSE GENERATOR IMPLANT RATES WERE EVALUATED. THOSE WHO HAD RECEIVED AN IMPLANTABLE PULSE GENERATOR WERE FURTHER EVALUATED OVER TIME FOR COMPLICATIONS, REVISIONS, EXPLANTATIONS, AND REPROGRAMMING SESSIONS COLLECTED FROM THE MEDICAL RECORDS. THE SYMPTOM CHANGES FROM BASELINE OVER 2 YEARS WERE MEASURED USING PATIENT-COMPLETED VOIDING DIARIES, THE INTERSTITIAL CYSTITIS SYMPTOM-PROBLEM INDEX, OVERACTIVE BLADDER QUESTIONNAIRE, THE MEDICAL OUTCOMES STUDY SHORT FORM, 12-ITEM HEALTH SURVEY, VERSION 2, PHYSICAL AND MENTAL COMPONENT SUBSCALES, AND A SCALED GLOBAL RESPONSE ASSESSMENT. THE DATA WERE EXAMINED USING PEARSON¿S CHI-SQUARE TEST OR FISHER¿S EXACT TEST, WILCOXON RANK TESTS, AND REPEATED MEASURES ANALYSES. OF 340 PATIENTS, 63 OF 71 (88.7%) WITH AN ND AND 241 OF 269 (89.6%) WITHOUT AN ND HAD AN IMPLANTABLE PULSE GENERATOR IMPLANTED (P ¼ .82). THE NDS CONSISTED OF STROKE (N ¼ 17), MULTIPLE SCLEROSIS (N ¼ 13), PARKINSON¿S DISEASE (N ¼ 10), INCOMPLETE SPINAL CORD INJURY (N ¼ 4), CEREBRAL PALSY (N ¼ 1), AND OTHERS. THE COMPLICATIONS, REVISIONS/EXPLANTS, AND REPROGRAMMING SESSIONS WERE SIMILAR BETWEEN THE 2 GROUPS. STATISTICALLY SIGNIFICANT IMPROVEMENTS WERE SEEN IN BOTH GROUPS OVER TIME ON THE VOIDING DIARY VARIABLES (EXCEPT FOR INCONTINENCE EPISODES AND SEVERITY IN THE ND GROUP), INTERSTITIAL CYSTITIS SYMPTOM-PROBLEM INDEX, AND OVERACTIVE BLADDER QUESTIONNAIRE. THE SHORT FORM, 12-ITEM, PHYSICAL AND MENTAL COMPONENT SUBSCALE SCORES ONLY IMPROVED SIGNIFICANTLY IN THOSE WITHOUT AN ND. MOST PATIENTS (>50%) IN BOTH GROUPS REPORTED MODERATE OR MARKED IMPROVEMENT IN OVERALL BLADDER SYMPTOMS AT EACH POINT USING THE GLOBAL RESPONSE ASSESSMENTS. PATIENTS WITH NEUROGENIC BLADDER DYSFUNCTION EXPERIENCE BENEFITS AFTER NEUROMODULATION SIMILAR TO THE BENEFITS EXPERIENCED BY THOSE WITHOUT COEXISTING NEUROLOGIC CONDITIONS. REPORTED EVENTS: 1. 30 PATIENTS HAD THEIR DEVICE REVISED. 2. 36 PATIENTS HAD THEIR DEVICE EXPLANTED. 3. 11 PATIENTS EXPERIENCED WOUND INFECTION. 4. 2 PATIENTS EXPERIENCED A SHOCKING SENSATION WITH STIMULATION. 5. 7 PATIENTS EXPERIENCED LEAD BREAKAGE. 6. 4 PATIENTS EXPERIENCED LEAD MIGRATION. 7. 9 PATIENTS EXPERIENCED DEVICE MALFUNCTION. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243332 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention "SEE H10...."