FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2153103
·
Received June 22, 2011
Report
- Report Number
- 3007566237-2011-04670
- Event Type
- Injury
- Date Received
- June 22, 2011
- Date of Event
- May 6, 2010
- Report Date
- May 30, 2011
- 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
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CATHETER WAS DISCONNECTED FROM THE PUMP DURING A SPINAL WASH-OUT SURGERY DUE TO INFECTED SPINAL HARDWARE. THE CATHETER WAS CUT DURING THE SURGERY. THE ENTIRE PUMP SYSTEM WAS THEN EXPLANTED. THIS RESULTED IN A PROLONGED HOSPITALIZATION. AS OF (B)(4) 2011 THE SEQUELA REPORTED WAS INCREASED SPASTICITY AS RESULT OF REMOVAL OF THE PUMP SYSTEM. THE PATIENT'S PARENTS WERE NOT SURE IF ANOTHER PUMP SYSTEM WOULD BE IMPLANTED. ON (B)(6) 2010, THE DOSE WAS DECREASED 97% TO MINIMUM RATE. THE MEDICATION IN THE PUMP WAS LIORESAL AT 365.7 MCG/DAY. THE PATIENT RECOVERED WITH SEQUELAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR | Male | Hospitalization| R | CATHETER: MODEL 8596SC, LOT# N115798006.| CATHETER: MODEL 8598A, LOT# N108919012.| EXPLANTED:| EXPLANTED: | IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8598A, LOT# N108919012| CATHETER: MODEL 8596SC, LOT# N115798006| EXPLANTED: |