ACTIVA
Report
- Report Number
- 2182207-2024-03945
- Event Type
- Injury
- Date Received
- September 19, 2024
- Date of Event
- September 12, 2024
- Report Date
- September 24, 2024
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- UDI-DI
- 00613994934611
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 003
Narratives
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.
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 INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THE CAUSE OF THE IMPEDANCE ISSUE WAS UNKNOWN. NO ACTIONS/INTERVENTIONS WERE PLANNED TO RESOLVE THE ISSUE.
IT WAS REPORTED THAT PATIENT'S THERAPY WAS NOT EFFECTIVE AT CONTROLLING TREMOR. THEREFORE, THEY TURNED OFF BOTH BATTERIES FOR ABOUT ONE YEAR. UPON INTERROGATING, THERE WERE MULTIPLE HIGH IMPEDANCES ON THE RIGHT BIPOLAR CONTACTS AND THE LEFT MONOPOLAR AND BIPOLAR CONTACTS. PATIENT WAS NOT RECEIVING STIMULATION ON THESE CONTACT CONFIGURATIONS. BOTH BATTERIES WERE REPLACED. ALL IMPEDANCES FOR THE RIGHT IMPROVED AND WERE WITHIN NORMAL LIMITS EXCEPT FOR THE 0 AND 3 BIPOLAR CONFIGURATION (94 OHMS). ALL IMPEDANCES THAT WERE PREVIOUSLY OUT OF RANGE FOR THE LEFT IMPROVED SLIGHTLY BUT REMAINED ABOVE 2,000 OHMS. SURGEON ATTEMPTED REINSERTING ELECTRODE FOR LEFT CONTACT AFTER WIPING WITH WET/DRY RAYTEK WITH LITTLE TO NO IMPROVEMENT TO IMPEDANCES. THE ISSUE DID NOT RESOLVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1747539 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS | MHY | MEDTRONIC NEUROMODULATION | 37612 | 00613994934611 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female | Required Intervention |