FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1062119
·
Received June 18, 2008
Report
- Report Number
- 2182207-2008-03322
- Event Type
- Injury
- Date Received
- June 18, 2008
- Date of Event
- February 1, 2008
- Report Date
- May 20, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-1151-2008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
REFERS TO CATHETER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. IT WAS REPORTED THAT SINCE THE PATIENT'S LAST REFILL, THE PATIENT DEVELOPED LOWER EXTREMITY WEAKNESS, LOSS OF SENSATION. THE PATIENT FELL SEVERAL TIMES AND AN AMBULANCE WAS CALLED TWICE. THE PATIENT ALSO EXPERIENCED LEG NUMBNESS AND BURNING SENSATIONS. IT WAS REPORTED THAT THE PATIENT'S PAIN WAS WORSE THAN BEFORE, AND THE PATIENT IS USING A CANE NOW, WHICH HE DID NOT USE PRIOR TO IMPLANT. THE PATIENT CONTINUES TO TAKE ORAL PAIN MEDICATIONS. NO PATIENT TREATMENT OR OUTCOME WAS REPORTED. THE DRUG CONTAINED IN THE PATIENT'S PUMP WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED| EXPLANTED| CATHETER MODEL 8709SC LOT# N130033014| PROGRAMMER MODEL 8840 LOT# UNKNOWN |