FDA Adverse Event
Injury
Summary report: N
SYNCHROMED
MDR report key: 1022165
·
Received March 26, 2008
Report
- Report Number
- 2182207-2008-01608
- Event Type
- Injury
- Date Received
- March 26, 2008
- Report Date
- April 2, 2007
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.
Description of Event or Problem · 1
LITERATURE: KRACH, LE ET AL. "SATISFACTION OF INDIVIDUALS TREATED LONG-TERM WITH CONTINUOUS INFUSION OF INTRATHECAL BACLOFEN BY IMPLANTED PROGRAMMABLE PUMP." PEDIATRIC REHABILITATION. 2006. 9(3): 210-218. ELEVEN PATIENTS WERE EXCLUDED FROM THE STUDY AS THEIR PUMPS HAD TO BE EXPLANTED DUE TO INFECTION PRIOR TO 1 YEAR AFTER IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED | LKK | MEDTRONIC NEUROMODULATION | PUMP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | EXPLANTED:| CATHETER MODEL CATHETER LOT# UNKNOWN| PROGRAMMER MODEL PROGRAMMER| LOT# UNKNOWN| IMPLANTED:| EXPLANTED:| IMPLANTED: |