BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME

    MDR report key: 19187975 · Received April 25, 2024

    Report

    Report Number
    3004209178-2024-09806
    Event Type
    Injury
    Date Received
    April 25, 2024
    Report Date
    April 25, 2024
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    UDI-DI
    00613994842299
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME INTERSTIM; PRODUCT ID 3093-28 (LOT: V922002); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE (B)(6) 2013; BRAND NAME INTERSTIM; PRODUCT ID 3093-28 (LOT: V674600); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE (B)(6) 2013; MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A PATIENT (PT) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL PELVIC FLOOR, URINARY DYSFUNCTION/SACRAL NERVE STIM, AND FECAL INCONTINENCE. THE REASON FOR CALL WAS TO GET MRI INFORMATION. PATIENT REPORTS THAT THEY HAD THE DEVICE REMOVED BECAUSE IT WASN'T HELPING WITH THEIR INCONTINENCE. PATIENT STATES THAT ONE OF THE METAL LEADS BROKE OFF INSIDE OF THEM AND THEY LEFT IT INSIDE DURING EXPLANT SURGERY. AGENT REVIEWED MRI INFORMATION AND REDIRECTED TO HEALTHCARE PROVIDER (HCP) FOR FURTHER ASSISTANCE. PATIENT STATED THE INS NEVER STOPPED WORKING, BUT NEVER DID WORK. PT MENTIONED THE BATTERY WAS LARGE AND UNCOMFORTABLE IN THEIR BODY BECAUSE THEY WERE ONLY 125LBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147330 RESTORE PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37701 00613994842299

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention SEE H11...