BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 4888675 · Received July 2, 2015

    Report

    Report Number
    3004209178-2015-12698
    Event Type
    Injury
    Date Received
    July 2, 2015
    Date of Event
    June 9, 2015
    Report Date
    January 25, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID 3031A, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3093-28, LOT# V250970, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID 3031A, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID 3037 SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE PRODUCT ID 3095-10 (B)(4) IMPLANTED: (B)(6) EXPLANTED: (B)(6) PRODUCT TYPE EXTENSION PRODUCT ID 3093-28 LOT# V250970 IMPLANTED: (B)(6) EXPLANTED: (B)(6) PRODUCT TYPE LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE WAS TOLD AT THE HEALTH CARE PROVIDER'S (HCP) OFFICE 2 WEEKS AGO THAT THE "WIRES ARE BROKEN INSIDE HER BODY AND THE ONLY WAY TO FIX IT WAS WITH SURGERY. THE PATIENT STATED SHE WAS NOT GOING TO DO SURGERY. THE PATIENT MENTIONED THAT SHE WANTED TO LOWER THE IMPLANTABLE NEUROSTIMULATOR (INS) BECAUSE THE HCP MADE IT HIGHER FOR HER. THE PATIENT STATED THEIR PROGRAMMER WAS NOT WORKING. THE PATIENT INDICATED THAT SHE TRIED TO ADJUST THE STIMULATION ON THE DAY OF THIS CALL BUT COULD NOT GET THE PROGRAMMER TO WORK. THE PATIENT DESCRIBE THE SCREEN AS A "SQUARE AND A PROGRAMMER WITH SOMETHING CUT OUT OF IT." THE PATIENT TECHNICAL SERVICE DETERMINED PATIENT WAS DESCRIBING THE REPLACE PROGRAMMER BATTERY SCREEN. THE PATIENT WOULD CHANGE THE BATTERIES AND TRY THE PROGRAMMER. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. A FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR. THE CALLER MENTIONED THE PREVIOUSLY DOCUMENTED ISSUE OF THE PREVIOUS IMPLANT BEING ¿BROKEN¿. THE CALLER STATED THE IMPLANT HAD BEEN REPLACED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432718 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Required Intervention