PERCEPT
Report
- Report Number
- 3004209178-2024-08849
- Event Type
- Malfunction
- Date Received
- April 10, 2024
- Date of Event
- April 2, 2024
- Report Date
- May 6, 2024
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- PJS
- UDI-DI
- 00763000642174
- 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 CONSUMER REPORTED THE CAUSE OF THE SHOCK WAS DUE TO THEM TURNING THE HANDSET ON AND ACCIDENTALLY TURNING THERAPY OFF AND THE COMMUNICATOR BEING IN ANOTHER ROOM. THE CONSUMER SPOKE WITH THE MANUFACTURER WHO HELPED TURN THERAPY BACK ON WHICH RESOLVED THE ISSUE.
INFORMATION WAS RECEIVED FROM A PATIENT'S REPRESENTATIVE REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). CALLER STATED THAT THE WHEN THEY CAME BACK FROM THE GROCERY STORE, THE PATIENT WENT TO TURN ON THE HANDSET STATED THAT THEY FELT LIKE THEIR BRAIN WAS GETTING A SHOCK AND HIS VOICE SOUNDED LIKE RFK JUNIORS. CALLER STATED THAT THEY ARE UNSURE WHAT THE PATIENT DID WITH THE HANDSET. PATIENT SERVICES (PSS) HAD THE CALLER CONNECT TO THE DBS THERAPY APP AND THE CALLER STATED THAT THE INS WAS TURNED OFF. THE CALLER CONFIRMED THAT THEY WERE ABLE TO TURN THERAPY BACK ON, AND THE PATIENTS SYMPTOMS STARTED TO SUBSIDE. THE TROUBLESHOOTING STEPS THAT WERE TAKEN RESOLVED THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1974951 | PERCEPT | STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI | PJS | MEDTRONIC PUERTO RICO OPERATIONS CO. | B35200 | 00763000642174 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Male |