SYNCHROMED II
Report
- Report Number
- 3004209178-2025-04244
- Event Type
- Injury
- Date Received
- March 7, 2025
- Date of Event
- September 9, 2024
- Report Date
- November 20, 2025
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- UDI-DI
- 00763000689520
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID: 8780, LOT#: 0210898520, IMPLANTED: ON (B)(6) 2017, PRODUCT TYPE: CATHETER. 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.
G3 CORRECTION/UPDATE: THE DATE MANUFACTURER RECEIVED INDICATED 2025-MAR-05 REGARDING THE INITIAL REPORT; HOWEVER, WAS SINCE UPDATED TO 2025-MAR-04. B5 CORRECTION: THE INITIAL REPORT INDICATED THAT ANOTHER MOTOR STALL OCCURRED ON (B)(6) 2024 AT 8:42 PM AND A RECOVERY NOTED ON (B)(6) 2024 AT 9:03 PM IN ERROR (DATE ERROR). THE FIELD B5 HAS SINCE BEEN UPDATED TO INDICATE THE FOLLOWING INSTEAD: ANOTHER MOTOR STALL OCCURRED ON (B)(6) 2024 AT 8:42 PM AND A RECOVERY NOTED ON (B)(6) 2024 AT 9:03 PM. 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 PUMP WAS SUBJECTED TO A SERIES OF STANDARD TESTS THAT INCLUDE BUT IS NOT LIMITED TO VISUAL INSPECTION, ALARM OUTPUT, MOTOR FUNCTION, AND DISPENSE TESTING. THE PUMP 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 RECEIVED FROM A FOREIGN HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE. AS PER THE PUMP LOGS PROVIDED, ADDITIONAL MOTOR STALLS OCCURRED. THE LOGS PROVIDED INDICATED THE FOLLOWING OCCURRED: ON (B)(6) 2024 6:15 PM ¿ CRITICAL ALARM ¿ PUMP MOTOR STALL OCCURRED, ON (B)(6) 2024 6:20 PM ¿ PUMP MOTOR STALL RECOVERY, ON (B)(6) 2024 8:38 PM - CRITICAL ALARM ¿ PUMP MOTOR STALL OCCURRED, ON (B)(6) 2024 8:59 PM ¿ PUMP MOTOR STALL RECOVERY, ON (B)(6) 2025 3:41 PM - CRITICAL ALARM ¿ PUMP MOTOR STALL OCCURRED, ON (B)(6) 2025 3:46 PM ¿ PUMP MOTOR STALL RECOVERY, ON (B)(6) 2025 10:48 PM - CRITICAL ALARM ¿ PUMP MOTOR STALL OCCURRED, ON (B)(6) 2025 10:53 PM ¿ PUMP MOTOR STALL RECOVERY, ON (B)(6) 2025 4:03 PM ¿ CRITICAL ALARM ¿ PUMP MOTOR STALL OCCURRED, ON (B)(6) 2025 4:08 PM - PUMP MOTOR STALL RECOVERY, ON (B)(6) 2025 9:12 AM - CRITICAL ALARM ¿ PUMP MOTOR STALL OCCURRED, AND ON (B)(6) 2025 10:11 AM ¿ PUMP MOTOR STALL RECOVERY. THE PATIENT WAS NOT IN CONTACT WITH ANY ELECTROMAGNETIC INTERFERENCE. THE CAUSE OF THE INTERMITTENT MOTOR STALLS WAS NOT IDENTIFIED. THE PHYSICIAN HAD REQUESTED A POSSIBLE EXPLANATION FOR ALL THE MOTOR STALLS THAT HAD OCCURRED. THE PATIENT STILL HAD THE PUMP IMPLANTED. THE PATIENT¿S CATHETER WAS IMPLANTED ON (B)(6) 2017. AS PER THE PUMP¿S LOG, THE PUMP ADMINISTERED HYDROMORPHONE WITH CONCENTRATION 2, 000.0 MCG/ML AT A DOSE RATE OF 299.8 MCG/DAY AS ON (B)(6) 2025.
ADDITIONAL INFORMATION RECEIVED FROM A FOREIGN HEALTH CARE PROVIDER (FOR, HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) INDICATED THAT FURTHER ACTIONS/INTERVENTIONS TAKEN TO RESOLVE THE EVENT INCLUDED MONTHLY INTERROGATION OF THE PUMP TO CHECK WORKING ORDER OF THE PUMP HAD BEEN REQUESTED BY THE PHYSICIAN. THE ISSUE HAD NOT RESOLVED AND THEY WERE JUST WAITING TO SEE IF MORE MOTOR STALLS OCCUR.
INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROVIDER (HCP) AND PATIENT (CON) VIA A COMPANY REPRESENTATIVE (REP) REGARDING THE PATIENT RECEIVING HYDROMORPHONE ((2,000.0 MCG/ML, 609.2 MCG/DAY) VIA IMPLANTED INFUSION PUMP. IT WAS REPORTED THAT ON (B)(6) 2025, THE REP WAS ASKED TO INVESTIGATE THE PATIENT'S DRUG PUMP AS IT HAD ALARMED A FEW TIMES OVER THE LAST 6 MONTHS. THE PATIENT HAD BEEN AT HOME WHEN CRITICAL ALARM WAS HEARD. NO WITHDRAWALS OR ANY OTHER SYMPTOMS OF LOSS OF THERAPY HAVE OCCURRED. THE CRITICAL ALARM RECOVERED A SHORT TIME AFTER. THE PATIENT REPORTED THAT THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE PATIENT DID NOT HAVE ANY MRI'S, NO BED MAGNETS, NO FALLS ETC. THE PUMP WAS INTERROGATED AT THE REQUEST OF PHYSICIAN TO CHECK ON WHY THE MOTOR STALL IS OCCURRING. LOGS WERE RETRIEVED. NO INTERVENTIONS TAKEN EXCEPT TO INTERROGATE AND CHECK THE STATE OF THE PUMP. THE ISSUE WAS RESOLVED AT THE TIME OF THE EVENT. NO SYMPTOMS DISPLAYED OR REPORTED BY PATIENT. THE ISSUE WAS RESOLVED AT TIME OF EVENT. IT WAS REPORTED THAT THERE POSSIBLY WILL BE A REPLACEMENT IF THE IMPLANTED PRODUCT WAS FAULTY, BUT CURRENTLY THERE WAS NO SURGICAL INTERVENTION PLANNED OR OCCURRED. THE PATIENT'S STATUS WAS ALIVE - NO INJURY. ACCORDING TO THE LOGS PROVIDED, A MOTOR STALL OCCURRED ON (B)(6) 2024 AT 6:19 PM AND RECOVERED ON (B)(6) 2024 AT 6:24 PM. ANOTHER MOTOR STALL OCCURRED ON (B)(6) 2024 AT 8:42 PM AND A RECOVERY NOTED ON (B)(6) 2024 AT 9:03 PM. A THIRD MOTOR STALL OCCURRED ON (B)(6) 2025 AT 3:45 PM AND RECOVERED ON (B)(6) 2025 AT 3:50 PM.
INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROVIDER (HCP) AND PATIENT (CON) VIA A COMPANY REPRESENTATIVE (REP) REGARDING THE PATIENT RECEIVING HYDROMORPHONE ((2,000.0 MCG/ML, 609.2 MCG/DAY) VIA IMPLANTED INFUSION PUMP. IT WAS REPORTED THAT ON (B)(6) 2025, THE REP WAS ASKED TO INVESTIGATE THE PATIENT'S DRUG PUMP AS IT HAD ALARMED A FEW TIMES OVER THE LAST 6 MONTHS. THE PATIENT HAD BEEN AT HOME WHEN CRITICAL ALARM WAS HEARD. NO WITHDRAWALS OR ANY OTHER SYMPTOMS OF LOSS OF THERAPY HAVE OCCURRED. THE CRITICAL ALARM RECOVERED A SHORT TIME AFTER. THE PATIENT REPORTED THAT THERE WERE NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE PATIENT DID NOT HAVE ANY MRI'S, NO BED MAGNETS, NO FALLS ETC. THE PUMP WAS INTERROGATED AT THE REQUEST OF PHYSICIAN TO CHECK ON WHY THE MOTOR STALL IS OCCURRING. LOGS WERE RETRIEVED. NO INTERVENTIONS TAKEN EXCEPT TO INTERROGATE AND CHECK THE STATE OF THE PUMP. THE ISSUE WAS RESOLVED AT THE TIME OF THE EVENT. NO SYMPTOMS DISPLAYED OR REPORTED BY PATIENT. THE ISSUE WAS RESOLVED AT TIME OF EVENT. IT WAS REPORTED THAT THERE POSSIBLY WILL BE A REPLACEMENT IF THE IMPLANTED PRODUCT WAS FAULTY, BUT CURRENTLY THERE WAS NO SURGICAL INTERVENTION PLANNED OR OCCURRED. THE PATIENT'S STATUS WAS ALIVE - NO INJURY. ACCORDING TO THE LOGS PROVIDED, A MOTOR STALL OCCURRED ON (B)(6) 2024 AT 6:19 PM AND RECOVERED ON (B)(6) 2024 AT 6:24 PM. ANOTHER MOTOR STALL OCCURRED ON (B)(6) 2024 AT 8:42 PM AND A RECOVERY NOTED ON (B)(6) 2024 AT 9:03 PM. A THIRD MOTOR STALL OCCURRED ON (B)(6) 2025 AT 3:45 PM AND RECOVERED ON (B)(6) 2025 AT 3:50 PM.
ADDITIONAL INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE (REP) REPORTING THAT THE PATIENT'S PUMP WAS REPLACED. THE REP REVIEWED LOGS AND ASKED PATIENT ABOUT HER ENVIRONMENT, IF USING LAPTOP/ TABLET WHILE SITTING ON HER LAP. THERE WERE NO APPLICABLE ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE PATIENT'S WEIGHT WAS ASKED, BUT UNKNOWN. THE PATIENT'S STATUS WAS ALIVE - NO INJURY. THE ISSUE WAS RESOLVED AT THE TIME OF REPORT. THE PUMP WAS EXPLANTED ON (B)(6) 2025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1139931 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 8637-40 | 00763000689520 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention | SEE H11.... |