SYNCHROMED
Report
- Report Number
- 3007566237-2013-02122
- Event Type
- Malfunction
- Date Received
- June 26, 2013
- Report Date
- June 4, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
CORRECTED/ADDITIONAL INFORMATION: WITH THE NEW INFORMATION RECEIVED, ALL PREVIOUSLY REPORTED PATIENT AND DEVICE CODES ARE BEING UPDATED TO THE FOLLOWING FOR THIS EVENT: (B)(4).
CORRECTED INFORMATION: DEVICE CODE IS NOT APPLICABLE FOR THIS EVENT. (B)(4).
(B)(4).
IT WAS REPORTED THAT WITHIN THE LAST TWO MONTHS, A VERY OLD PUMP WAS REPLACED; IT HAD A TIE ON CONNECTOR BETWEEN THE PUMP NIPPLE AND THE CATHETER. THE TIE HAD ERODED THE PLASTIC. IT RESULTED IN CSF (CEREBROSPINAL FLUID) IN THE POCKET AND/OR THE CATHETER WAS OBSTRUCTED BY THE INVADING SCAR TISSUE; IT WAS UNCLEAR WHICH HAPPENED IN THIS CASE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT FOR THIS PATIENT THERE WAS PARTIAL SEPARATION WITH FIBROUS INGROWTH THROUGH THE DEFECT CAUSING OCCLUSION. THE CATHETER WAS LESS THAN 7 YEARS OLD. THE EVENT HAPPENED WITHIN THE LAST YEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 289840 | SYNCHROMED | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |