FDA Adverse Event
Injury
Summary report: N
SYNCHROMED
MDR report key: 1222425
·
Received November 5, 2008
Report
- Report Number
- 2182207-2008-07221
- Event Type
- Injury
- Date Received
- November 5, 2008
- Date of Event
- September 1, 2008
- Report Date
- October 10, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-2380-2008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE CATHETER HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
THE PATIENT EXPERIENCED INCREASED SPASTICITY AND UNSPECIFIED SYMPTOMS OF PULMONARY EMBOLISM. THE PHYSICIAN THOUGHT THAT THE CATHETER COULD BE THE REASON. THE CATHETER WAS REPLACED. AFTER THE REPLACEMENT, THE PATIENT SHOWED A GOOD THERAPY OUTCOME; THERE WERE NO FURTHER PROBLEMS. THERE WAS NO PATIENT INJURY. THE PUMP WAS USED TO DELIVER LIORESAL.
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 8709SC LOT# B0803347K| IMPLANTED: |