SYNCHROMED III
Report
- Report Number
- 3004209178-2025-04710
- Event Type
- Injury
- Date Received
- March 17, 2025
- Date of Event
- March 4, 2025
- Report Date
- May 19, 2025
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- UDI-DI
- 00763000597023
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
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.
H3. THE RETURNED DEVICE PASSED ALL TESTING IN THE LABORATORY AND NO ANOMALIES WERE IDENTIFIED. 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 WAS PROVIDED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE (REP) STATED THAT THE PUMP AND CATHETER WERE REPLACED AND RETURNED. ADDITIONAL INFORMATION WAS PROVIDED FROM A COMPANY REPRESENTATIVE (REP) STATED THAT THE DRUG INFORMATION WAS FENTANYL WAS 997.7 MCG/DAY 7,000 MCG/ML.
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT RECEIVING AN UNKNOWN DRUG VIA AN IMPLANTABLE PUMP. IT WAS REPORTED THAT THE PUMP HAD BEEN INTERMITTENTLY STALLING. THE PUMP WAS INTERROGATED AND THE LOGS WERE READ. THE MOTOR STALL AND RECOVERIES OCCURRED AT THE FOLLOWING DATES AND TIMES: STALL ON (B)(6) 2024 AT 5:05PM, RECOVERY ON (B)(6) 2024 AT 5:49PM. STALL ON (B)(6) 2024 AT 5:09PM, RECOVERY ON (B)(6) 2024 AT 5:45PM. STALL ON (B)(6) 2024 AT 7:46PM, RECOVERY ON (B)(6) 2024 AT 7:54PM. STALL ON (B)(6) 2024 AT 3:01AM, RECOVERY ON (B)(6) 2024 AT 3:17AM. STALL ON (B)(6) 2025 AT 9:19PM, RECOVERY ON (B)(6) 2025 AT 9:47PM. STALL ON (B)(6) 2025 AT 7:58PM, RECOVERY ON (B)(6) 2025 AT 8:07PM. STALL ON (B)(6) 2025 AT 4:26PM, RECOVERY ON (B)(6) 2025 AT 5:22PM. STALL ON (B)(6) 2025 AT 8:31PM, RECOVERY ON (B)(6) 2025 AT 9:18PM. STALL ON (B)(6) 2025 AT 1:31PM, RECOVERY ON (B)(6) 2025 AT 1:51PM. STALL ON (B)(6) 2025 AT 8:30PM, RECOVERY ON (B)(6) 2025 AT 8:42PM. STALL ON (B)(6) 2025 AT 5:36PM, RECOVERY ON (B)(6) 2025 AT 6:41PM. STALL ON (B)(6) 2025 AT 7:49PM, RECOVERY ON (B)(6) 2025 AT 8:05PM. STALL ON (B)(6) 2025 AT 12:08PM, RECOVERY ON (B)(6) 2025 AT 12:43PM. STALL ON (B)(6) 2025 AT 11:54AM, RECOVERY ON (B)(6) 2025 AT 12:02PM. STALL ON (B)(6) 2025 AT 5:36PM, RECOVERY ON (B)(6) 2025 AT 6:14PM. STALL ON (B)(6) 2025 AT 8:54PM, RECOVERY ON (B)(6) 2025 AT 9:07PM. STALL ON (B)(6) 2025 AT 2:13PM, RECOVERY ON (B)(6) 2025 AT 2:41PM. STALL ON (B)(6) 2025 AT 5:20PM, RECOVERY ON (B)(6) 2025 AT 5:44PM. STALL ON (B)(6) 2025 AT 3:29PM, RECOVERY ON (B)(6) 2025 AT 4:07PM. A PUMP REPLACEMENT WAS PLANNED BUT NOT SCHEDULED. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE COMPANY REPRESENTATIVE (REP) REPORTING THAT PATIENT DID NOT THINK HE WAS GETTING NEAR ANYTHING MAGNETIC TO CAUSE THE STALLS.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) VIA THE COMPANY REPRESENTATIVE (REP) REPORTING THAT THE PATIENT HAD A SYSTEM REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3047 | SYNCHROMED III | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 8667-20 | 00763000597023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Male | Required Intervention | "SEE H11...."| "SEE H11...." |