BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTAVIVA

    MDR report key: 24830264 · Received April 9, 2026

    Report

    Report Number
    3004209178-2026-06190
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    January 20, 2026
    Report Date
    May 21, 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
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS OF THE INS (S/N: (B)(6) REVEALED THE IMPLANTABLE NEUROSTIMULATOR (INS) PASSED FUNCTIONAL TESTING. 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.

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. 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.

    Additional Manufacturer Narrative · 0

    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 WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DYSFUNCTION. IT WAS REPORTED THAT THEY HAVE CALF PAIN MORNING AFTER IMPLANT. PATIENT REPORTED CALF PAIN HAD IMPROVED THROUGHOUT THE WEEK, HOWEVER, TODAY IS REPORTING CALF PAIN STILL PRESENT AND LIMITING MOBILITY. EXPERIENCED EXCRUCIATING CALF PAIN THAT IS CONTINUOUS. THEY HAVE TAKEN IBUPROFEN AND SPOKEN WITH BOTH THE MANUFACTURER REPRESENTATIVE AND THE PHYSICIAN'S ASSISTANT AT THEIR MANAGING PHYSICIAN'S OFFICE WHO TOLD PATIENT TO REDUCE THE AMOUNT THEY ARE WALKING. PATIENT CONFIRMED THE PAIN IS NOT RELATED TO STIMULATION AND IS THERE CONTINUOUSLY REGARDLESS WHEN THERAPY SESSIONS ARE ACTIVE OR NOT. IT IS WORSE WHEN THEY FLEX THEIR FOOT TOWARDS THEIR ANKLE. PATIENT HAS A FOLLOW UP APPOINTMENT WITH MANAGING PHYSICIAN ON WEDNESDAY MORNING AND NOTED THAT A MANUFACTURER REPRESENTATIVE WILL BE PRESENT. ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE PATIENT CALLED BACK REPORTING THEY MET WITH THEIR PHYSICIAN AND MANUFACTURER REPRESENTATIVE (REP) YESTERDAY AT THE PHYSICIAN'S OFFICE REGARDING THE CALF PAIN. THE PHYSICIAN THOUGHT THE PAIN MAY BE CAUSED BY SEROMA/FLUID BUILD UP. HOWEVER PATIENT STATED THAT ACCORDING TO THE REP, THAT HAS NOT BEEN EXPERIENCED IN ANYONE. REVIEWED SEROMA IS A POSSIBLE RISK AND SENT PATIENT A COPY OF THE PATIENT GUIDE WHICH INCLUDES INFORMATION ABOUT RISKS AND CLINICAL STUDY PER PATIENT REQUEST. PATIENT ALSO NOTED THEY ARE STILL NOT WALKING WELL AND PLAN TO FOLLOW UP WITH THEIR PHYSICIAN. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2026, THE REP STATED THAT PATIENT HAD AN INFECTION - INCLUDING DISCOMFORT AND FLUID COMING OUT AND INQUIRED ABOUT HOW TO PROCEED. TSS REVIEWED LABELING DOES NOT SPEAK HOW TO HANDLING INFECTION AND THAT THIS WOULD BE HCP'S DISCRETION. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE EXCRUCIATING CALF PAIN WAS NOT RELATED TO THE THERAPY OR HOW THE PROCEDURE WAS DONE. THE PROVIDER DID NOT BELIEVE THE PATIENT HAD AN INFECTION. PROVIDER BELIEVED IT WAS POSSIBLE THE DISCOMFORT WAS DUE TO A SEROMA. IT APPEARED THERE WAS SOME FLUID IN WHERE THE SITE OF IMPLANTATION WAS. BACTRIM WAS PRESCRIBED AFTER THE INITIAL DISCOMFORT WAS REPORTED. PROVIDER RECOMMENDED ELEVATION, COMPRESSION STOCKING, AND MOVEMENT WHEN POSSIBLE. THE ISSUE WAS RESOLVED. PATIENT WAS SEEN RECENTLY AND THE DISCOMFORT THEY EXPERIENCED IS MUCH BETTER. THE IMPLANT SITE LOOKS TO BE HEALING APPROPRIATELY AS WELL AS ANY SWELLING THAT APPEARED AFTER THE FIRST VISIT. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT PATIENT REPORTED A SCAB AND REDNESS AROUND THE INCISION SITE. THEY CAME IN TO SEE THE PHYSICIAN TODAY WHO CLEANED THE SITE AND PLACED ANOTHER BANDAGE ON TOP. PROVIDER WILL BE FOLLOWING UP WITH PATIENT IN 2 DAYS TO SEE HOW HEALING IS. PATIENTS CALF PAIN HAS RESOLVED, BUT IS STILL EXPERIENCING TENDERNESS AND DISCOMFORT IF PRESSURE IS APPLIED TO THE INCISION SITE. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE PATIENT RETURNED TO THE OFFICE AFTER THE VISIT ON MONDAY. THERE WAS STILL SOME INFLAMMATION AND SORENESS IN THE AREA OF INCISION. PROVIDER AND PATIENT DECIDED TOGETHER THAT THEY WOULD LIKE TO REMOVE THE DEVICE. THE DEVICE WAS EXPLANTED ON (B)(6) 2026 BY HCP. ADDITIONAL RELEVANT INFORMATION, THE PATIENT WAS GIVEN ANTIBIOTICS THE DAY OF THE PROCEDURE. WAS ON ANTIBIOTICS FOR 5 DAYS FOLLOWING AND WAS PUT BACK ON ANTIBIOTICS AFTER THE FOLLOW UP VISIT WHEN THEY RETURNED WITH CALF PAIN. ALSO, ON THE VISIT ON MONDAY (B)(6) WHILE THE PHYSICIAN WAS CLEANING THE WOUND IT APPEARED THERE WAS STILL SOME GLUE AND SUTURE UNDER THE SCAB. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP). THE HCP REPORTED THAT THEY SAW THE PATIENT IN THE OFFICE PRIOR TO EXPLANT ON MULTIPLE OCCASIONS. THE PATIENT EXPERIENCED PAIN, DISCOMFORT, SWELLING, REDNESS, DISCHARGE AND AMBULATION DIFFICULTIES. THE PATIENT WILL NOT REPLACE IT IN THE FUTURE. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE DEVICE WAS EXPLANTED. NO ADDITIONAL FOLLOW UP FROM PATIENT. IT WAS NOT CONFIRMED THAT THE PATIENT HAD AN INFECTION. PATIENT WAS ON ANTIBIOTICS POST OP AND GIVEN AN ADDITIONAL 5 DAYS AT FOLLOW UP VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53315 ALTAVIVA STIMULATOR, TIBIAL, ELECTRICAL, IMPLANTABLE, FOR URINARY INCONTINENCE QPT MEDTRONIC PUERTO RICO OPERATIONS CO. P7850N 00763000936433

    Patients

    Seq Age Sex Outcome Treatment
    1