FDA Adverse Event
Injury
Summary report: N
SYNCHROMED
MDR report key: 1019451
·
Received March 26, 2008
Report
- Report Number
- 2182207-2008-01585
- Event Type
- Injury
- Date Received
- March 26, 2008
- Report Date
- April 24, 2007
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.
Description of Event or Problem · 1
LITERATURE: JOZWIAK, "USE OF A BACLOFEN PUMP IN THE TREATMENT OF SPASTICITY IN CHILDREN WITH CEREBRAL PALSY." PEDIATRIA POLSKA (POLISH PEDIATRICS). FEBRUARY 2007- 82 (2):131-36. TWO PATIENTS EXPERIENCED INFECTION IN THE POSTOPERATIVE WOUND WITH PUS DISCHARGE FROM THE AREA OF THE "BACLOFEN PUMP (SYNCHROMED II OR EL) WHICH CAUSED THE PUMPS TO BE REMOVED.
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 | IMPLANTED:| PROGRAMMER MODEL PROGRAMMER LOT# UNK| EXPLANTED:| CATHETER MODEL CATHETER LOT# UNK| IMPLANTED:| EXPLANTED: |