SYNCHROMED II
Report
- Report Number
- 3004209178-2018-21776
- Event Type
- Malfunction
- Date Received
- September 28, 2018
- Report Date
- January 15, 2019
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LKK
- UDI-DI
- 00643169530126
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780 LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2018, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: CATHETER, PRODUCT ID: 8780 LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2017, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: CATHETER, PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2018, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: CATHETER, PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2017, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: CATHETER, H3: THE CATHETERS (B)(6) WERE RETURNED AND ANALYSIS IDENTIFIED TWISTING. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2018, PRODUCT TYPE: CATHETER. PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2017, PRODUCT TYPE: CATHETER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2018, PRODUCT TYPE: CATHETER. PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2017, PRODUCT TYPE: CATHETER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) VIA DEVICE MANUFACTURER REPRESENTATIVE REGARDING A PATIENT RECEIVING UNKNOWN MEDICATION AT UNKNOWN CONCENTRATION AND DOSAGE VIA AN IMPLANTABLE INFUSION PUMP FOR THE TREATMENT OF NON-MALIGNANT PAIN. IT WAS REPORTED THAT THERE WAS EXCESS RESIDUAL VOLUME OF 10 CC AT PATIENT'S PUMP REFILL. NO FURTHER COMPLICATION WAS REPORTED.
ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER INDICATED THAT THE PATIENT'S PUMP WAS FILLED TWO WEEKS AGO AND THE HEALTHCARE PROVIDER (HCP) STATED THAT THE DEVICE WAS NOT WORKING. IT WAS REPORTED THAT IN A 2 MONTH PERIOD THE PUMP HAD ONLY USED 5MG WHEN IT SHOULD HAVE USED 40 MG OF MEDICATION. IT WAS NOTED THAT A DYE STUDY WAS NOT PERFORMED AND THE CATHETER WAS REVISED ON (B)(6) 2018. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE INDICATED A SECOND VOLUME DISCREPANCY OCCURRED (EXCESS RESIDUAL VOLUME) AT REFILL; DATE NOT REPORTED. THE PATIENT WAS BEING SCHEDULED FOR A DYE STUDY ON (B)(6) 2018. IT WAS NOTED THE PATIENT WAS RECEIVING UNKNOWN MORPHINE 10.0MG/ML; 2.48MG/DAY.
ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER REPORTED THE PATIENT'S CATHETER WAS NOT WORKING RIGHT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 758601 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC PUERTO RICO OPERATIONS CO. | 8637-40 | 00643169530126 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |