FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED
MDR report key: 1973639
·
Received January 18, 2011
Report
- Report Number
- 3007566237-2011-00420
- Event Type
- Malfunction
- Date Received
- January 18, 2011
- Date of Event
- January 11, 2011
- Report Date
- January 11, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT PRESENTED WITH A REDUCTION IN INTRATHECAL THERAPY EFFICACY. THE PHYSICIAN DID A RADIOGRAPHY AND SAW THAT A CATHETER FRAGMENT HAD BROKEN OFF THE CATHETER AND HAD SLIGHTLY MIGRATED CEPHALICALLY. AT THE MOVEMENT, THE PT DID NOT PRESENT ANY SYMPTOMATOLOGY RELATED TO THE CATHETER MIGRATION (EXCEPT FOR REDUCTION OF INTRATHECAL THERAPY EFFICACY). THE PHYSICIAN WAS PLANNING A NEW CATHETER IMPLANT. THE PT WAS REPORTED TO BE WELL. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
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 | EXPLANTED:| CATHETER: MODEL 8731SC, LOT # UNK| IMPLANTED: |