SYNCHROMED II
Report
- Report Number
- 3007566237-2013-01351
- Event Type
- Malfunction
- Date Received
- April 19, 2013
- Report Date
- March 21, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 8575, LOT# N061703, IMPLANTED: (B)(6) 2006, PRODUCT TYPE ACCESSORY; PRODUCT ID 8709, LOT# J0039955R, IMPLANTED: (B)(6) 2000, PRODUCT TYPE CATHETER; PRODUCT ID 8709, LOT# J0039955R, IMPLANTED: (B)(6) 2000, PRODUCT TYPE CATHETER. (B)(4). ANALYSIS OF THE PUMP FOUND NO SIGNIFICANT ANOMALY. ELECTIVE REPLACEMENT INDICATOR (ERI) WAS NOTED DUE TO TIME PROGRESSION.
IT WAS REPORTED THAT THE PUMP WAS EXPLANTED DUE TO EOL (END OF LIFE). IT WAS LATER REPORTED THAT ON (B)(6) 2012 THERE WAS AN INABILITY TO ASPIRATE FLUID; NO FREE FLOW OF CSF. ON (B)(6) 2012 AND ISOTOPE PUMP STUDY SHOWED 'NORMAL DELIVERY OF DRUG.' THE PUMP WAS REPLACED ON (B)(6) 2013. THE PATIENT HAD NO SIGNS OR SYMPTOMS. THE DEVICE SYSTEM WAS DELIVERING MORPHINE, CLONIDINE, BUPIVACAINE, AND BACLOFEN. IT WAS LATER REPORTED THAT WHEN THE PATIENT WAS TAKEN INTO THE OR FOR THE BATTERY REPLACEMENT, THE PUMP WAS DISCONNECTED FROM THE CATHETER, BUT THERE NO FREE FLOW OF CSF OBTAINED. A BACK TABLE FILL OF THE NEW PUMP WAS DONE AND THE CATHETER WAS LEFT IN PLACE. IT WAS LATER REPORTED THAT THE PATIENT RECOVERED WITHOUT SEQUELA.
IT WAS PREVIOUSLY REPORTED THAT THE PATIENT WAS TO BE SEEN FOR A POSTOPERATIVE VISIT "NEXT WEEK" TO CHECK THE WOUND TO RESOLVE THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 170774 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00052 YR |