SYNCHROMED II
Report
- Report Number
- 3007566237-2014-01376
- Event Type
- Injury
- Date Received
- May 20, 2014
- Date of Event
- April 29, 2014
- Report Date
- April 29, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER; PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.
ANALYSIS THE PUMP REVEALED WEAR OF THE O-RING OF THE MOTOR. ANALYSIS OF CATHETER SERIAL # (B)(4) REVEALED CORING/TEARS CUTS IN THE SEAL OF THE SUTURELESS CONNECTOR. NO LEAK WAS SEEN. ANALYSIS OF CATHETER SERIAL # (B)(4) REVEALED A HOLE (OR TORN CATHETER) IN THE CATHETER BODY, WHICH WAS CAUSED BY THE METAL PIN OF PUMP CONNECTOR POKING.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT WHEN THE NEUROSURGEON DISCONNECTED THE EXISTING CATHETER FROM THE PUMP FOR A PLANNED REPLACEMENT SECONDARY TO EXPECTED END OF LIFE BATTERY, NO RETROGRADE FLOW OF CEREBROSPINAL FLUID (CSF) WAS OBTAINED. THERE WAS NO EVIDENT KINK OR TEAR IN THE CATHETER UPON VISUALIZATION INTRA-OPERATIVELY. THE PATIENT HAD NOT BEEN SYMPTOMATIC FOR UNDERDOSE OR WITHDRAWAL PRIOR TO SURGERY. DUE TO NO BACKFLOW OF CSF EVEN WHEN AN ATTEMPT WAS MADE TO ASPIRATE FROM THE PROSIMAL END WITH A ¿TB¿ SYRINGE, THE NEUROSURGEON MADE THE CLINICAL DECISION TO REPLACE THE ENTIRE CATHETER AND RESTART THE PUMP ON A LOWER INFUSION RATE AFTER CONSULTING WITH THE MANAGING PHYSICIAN OVER THE PHONE. THE EVENT REQUIRED HOSPITALIZATION, EXPLANT, AND REPLACEMENT. NO DIAGNOSTIC TROUBLESHOOTING WAS REQUIRED. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED AND NO CAUSE WAS DETERMINED. ONCE THE CATHETER WAS REPLACED, THE INFUSION RATE WAS RESTARTED AT 500 MICROGRAMS PER DAY SIMPLE CONTINUOUS RATE AND THE PATIENT WAS ADMITTED FOR OBSERVATION OF POSSIBLE BACLOFEN OVERDOSE OR WITHDRAWAL OVER THE ENSUING 16 HOURS. THE PATIENT PRESENTED WITH INCREASED HYPERTONIA AND THE INFUSION RATE WAS INCREASED TO 575 MICROGRAMS PER DAY SIMPLE CONTINUOUS. THE PUMP HAD PREVIOUSLY BEEN DELIVERING AT 634.7 MICROGRAMS PER DAY. THE PATIENT HAD GENERALIZED HYPERTONIA THROUGHOUT THE BODY. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ¿ALIVE- NO INJURY.¿ THE SYSTEM WAS BEING USED TO DELIVER BACLOFEN.
IT WAS LATER REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL POST-OPERATIVELY FOR OBSERVATION AND THE SIMPLE CONTINUOUS INFUSION RATE WAS INCREASED FROM THE POST-OPERATIVE RATE OF 500MCG/DAY ON (B)(6) 2014 AT 10:27 TO 575MCG/DAY THE FOLLOWING DAY AT 16:39, TO 625MCG/DAY ON (B)(6) 2014 AT 11:39. THE PATIENT HAD NOT BEEN SEEN IN THE MANAGING HCP'S CLINIC SINCE HIS DISCHARGE FROM THE HOSPITAL ON (B)(6) 2014.
ADDITIONAL INFORMATION REPORTED IT WAS UNKNOWN HOW THE PATIENT WAS CURRENTLY DOING AS THE PATIENT HAD NOT RETURNED FOR FOLLOW-UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299963 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00038 YR | Hospitalization| R |