SYNCHROMED II
Report
- Report Number
- 2182207-2025-00032
- Event Type
- Malfunction
- Date Received
- January 6, 2025
- Date of Event
- December 30, 2024
- Report Date
- January 24, 2025
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION RECEIVED ON 2025-JAN-16 (INCLUDING THE CORRECT PUMP SERIAL NUMBER) DETERMINED THAT THE INFORMATION CAPTURED IN MANUFACTURER'S REPORT NUMBER: 3004209178-2025-00721 IS FROM THE SAME EVENT. PLEASE REFER TO MANUFACTURER'S REPORT NUMBER: 30042091 78-2025-00721 GOING FORWARD. 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 ON 2025-JAN-16 (INCLUDING THE CORRECT PUMP SERIAL NUMBER) DETERMINED THAT THE INFORMATION CAPTURED IN MANUFACTURER'S REPORT NUMBER: 3004209178-2025-00721 IS FROM THE SAME EVENT. PLEASE REFER TO MANUFACTURER'S REPORT NUMBER: 30042091 78-2025-00721 GOING FORWARD.
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, FOREIGN) REGARDING A PATIENT WHO W AS RECEIVING BACLOFEN WITH CONCENTRATION 3000 MCG/ML AT AN UNKNOWN DOSE RATE VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT'S PUMP WAS REPLACED IN JUNE OF 2024. THE DATE (B)(6) 2024 IS CONSIDERED AN APPROXIMATE DATE OF PUMP IMPLANT (SPECIFIC MONTH AND YEAR KNOWN ONLY. THE PUMP LATER HAD AN UNEXPLAINED MOTOR STALL THAT OCCURRED DURING THE NIGHT WHILE THE PATIENT WAS ASLEEP. THE PATIENT REPORTED A RETURN OF THEIR SPAMS. UPON CHECKING THE PUMP LOGS, A MOTOR STALL WAS IDENTIFIED AND THE PUMP WAS ALSO RESTARTED AGAIN SOON AFTER. THE HEALTHCARE PROVIDER INDICATED THAT IN THIS CASE THE PATIENT WAS NOT AWARE OF ANY STRONG SOURCE OF MAGNETS LIKE FOR EXAMPLE A MAGNETIC RESONANCE IMAGING (MRI) SCAN THAT HAD BEEN PERFORMED, OR OTHER SOURCES OF ELECTROMAGNETIC INTERFERENCE (EMI). FOR THIS REASON, THEY WANTED TO DOUBLECHECK WHAT COULD HAVE MIGHT CAUSED THE MOTOR STALL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1137862 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |