SYNCHROMED II
Report
- Report Number
- 3004209178-2024-18458
- Event Type
- Malfunction
- Date Received
- September 13, 2024
- Date of Event
- February 7, 2024
- Report Date
- September 12, 2025
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- UDI-DI
- 00643169630512
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID 8709 LOT# SERIAL# (B)(6) IMPLANTED: (B)(6) 2007, EXPLANTED: 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.
CONTINUATION OF D10: PRODUCT ID 8709 SERIAL# (B)(6) IMPLANTED: (B)(6) 2007 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.
CONTINUATION OF D10: PRODUCT ID 8709 LOT# SERIAL# (B)(6) IMPLANTED: (B)(6) 2007 EXPLANTED: PRODUCT TYPE CATHETER SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8709, SERIAL/LOT #: (B)(6) , UBD: 05-JAN-2009, UDI#: (B)(4) 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.
CONTINUATION OF D10: PRODUCT ID 8709. SERIAL# (B)(6). IMPLANTED: (B)(6) 2007: 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.
ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER VIA A CLINICAL STUDY INDICATED THAT ON (B)(6) 2024 VISIT, PATIENT REPORTED THAT SHE HAD SOME IMPROVEMENT OF ARM DYSTONIA FOLLOWING BOTULINUM INJECTIONS. THE ISSUE WAS REPORTED AS RESOLVED.
ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER VIA A CLINICAL STUDY INDICATED THAT THE PATIENT NOTED THAT HIS SPASTICITY WAS STABLE EVEN WITH THE WEANING. HE WAS TAKING ORAL BACLOFEN 10 MG AM AND AFTERNOON, 20 MG AT NIGHT, WITH LESS SPASTICITY AND IMPROVED REACHING WITH ARMS. AN INCREASE TO IN ORAL BACLOFEN TO 30MG PER DAY WAS PRESCRIBED.
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WHO WAS RECEIVING UNKNOWN BACLOFEN (2000 MCG AT 525.50249 MCG/DAY) VIA AN IMPLANTABLE PUMP FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT HAD SPASMS IN TOES AND THEIR FIRST TOE WAS CROSSING. IT WAS NOTED THAT THE PATIENT WORE TOE SEPARATORS AND STRETCHED WHEN STANDING. HE ALSO HAD REDNESS BETWEEN THE FIST AND SECOND TOES BILATERALLY. THE PATIENT WAS LATER SEEN IN THE HOSPITAL FOR SIDEPORT UNDER FLOURO, NO FLOW.THE PLAN WAS TO WEAN THE PATIENT SERIALLY. THE TAP WAS UNSUCCESSFUL, AND THE HEALTHCARE PROVIDER WAS UNABLE TO ACCESS THE SIDE PORT. THE PATIENT WAS GIVEN ORAL BALCOFEN. AN X-RAY DISPLAYED POSSIBLE DISCONTINUITY OF THE CATHETER.
ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER VIA A CLINICAL STUDY INDICATED THAT ON (B)(6) 2025. THE PATIENT REPORTED THAT HE"FEELS THAT SHOULDER RANGE OF MOTION HAS IMPROVED AS WELL WITH THE BACLOFEN TABLETS TAKEN". IT WAS NOTED THAT THE PUMP WAS TURNED OFF (B)(6) 2025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1535891 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 8637-40 | 00643169630512 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Male | "SEE H11....". |