BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTAVIVA

    MDR report key: 25320369 · Received May 28, 2026

    Report

    Report Number
    3004209178-2026-09100
    Event Type
    Injury
    Date Received
    May 28, 2026
    Date of Event
    May 8, 2026
    Report Date
    May 28, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    QPT
    UDI-DI
    00763000936433
    PMA / PMN Number
    P240011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: NON-ANALYZABLE MEDICAL ISSUE. 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 MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLAN TED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT HAD VASCULAR NECROSIS ON ANKLE THAT WAS IMPLANTED. NECROSIS WAS NEARLY AS BIG AS A QUARTER. THE PHYSICIAN MENTIONED THAT THEY PROBABLY SHOULDN'T HAD IMPLANTED DEVICE AND THEY WOULD BE MORE CAREFUL IN THE FUTURE. PATIENT PROVIDED ANTIBIOTICS. THE PHYSICIAN DID NOT THINK THE DEVICE CAUSED THIS ISSUE BUT RATHER PATIENT CONDITION UPON IMPLANTATION. PATIENT WAS EXPLANTED. PATIENT WAS SAD THOUGH BECAUSE THE DEVICE WAS WORKING. THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72671 ALTAVIVA STIMULATOR, TIBIAL, ELECTRICAL, IMPLANTABLE, FOR URINARY INCONTINENCE QPT MEDTRONIC PUERTO RICO OPERATIONS CO. P7850N 00763000936433

    Patients

    Seq Age Sex Outcome Treatment
    1