PERCEPT RC V1
Report
- Report Number
- 2182207-2024-02727
- Event Type
- Malfunction
- Date Received
- May 30, 2024
- Date of Event
- May 22, 2024
- Report Date
- July 2, 2024
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- UDI-DI
- 00763000564346
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 003
Narratives
SECTION D10 REFERENCES: PRODUCT ID A610, SERIAL# UNKNOWN, PRODUCT TYPE SOFTWARE. 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.
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) REPORTED THE ISSUE APPEARED TO BE A PROBLEM IN THE SOFTWARE OF THE TABLET. WHEN TRANSFERRING FROM A RIGHT SIDED SC BATTERY TO A DUAL CHANNEL PERCEPT RC, THE SYSTEM DEFAULT TRANSFERS THE SETTINGS INTO THE 0-3 PORT RATHER THAN THE TRADITIONAL 8-11 PORT RESERVED FOR RIGHT HEMISPHERE IMPLANTS.
IT WAS REPORTED THAT SETTINGS WERE TRANSFERRED USING CLINICAL PROGRAMMER FROM A 37603 RIGHT CHEST BATTERY TO A RIGHT CHEST. B35300 PERCEPT RC. DEVICE WAS TO BE SET UP AS ONLY POWERING RIGHT SIDE WITH A PORT PLUG IN PLACE. TRANSFERRING THE SETTINGS AUTOMATICALLY DROPPED THE LEAD AND POSITION INTO THE 0-3 TOP PORT NUMBERING USED FOR LEFT AND NOT THE 8-11 PORT NUMBERING TRADITIONALLY USED FOR RIGHT. SWITCHING THESE WOULD HAVE RESULTED IN WIPING THE SETTINGS FOR THE PATIENT SO THE RIGHT SIDE EXTENSION WAS PUT IN THE TOP 0-3 PORT INSTEAD OF THE BOTTOM 7-11 PORT. THIS WILL HAVE NO EFFECT ON THE PATIENT AS SHE HAS NO PLANS FOR A SECOND SIDE IMPLANT.
ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THEY FIGURED OUT THE DEVICE DEFAULTED EVERYTHING FROM AN SCA INTO THE 0-3 PORT, AND THEN WHEN THEY WENT THROUGH THE SET UP ON THE RECHARGEABLE DEVICE YOU HAVE TO CLICK THE SWITCH ICON ON THE COMPONENTS SCREEN AND IT WOULDN¿T WIPE OUT THE PROGRAMMING. THE ISSUE WAS AN AWARENESS ISSUE, NOT A SOFTWARE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1099354 | PERCEPT RC V1 | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | B35300 | 00763000564346 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Female |