FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1171220
·
Received September 22, 2008
Report
- Report Number
- 2182207-2008-05983
- Event Type
- Injury
- Date Received
- September 22, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 25, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS CODE OTHER = CATHETER.
Description of Event or Problem · 1
IT WAS REPORTED THE CATHETER PLACED IN THE CERVICAL SPINE MAY HAVE CLOSED OFF. THE CATHETER WAS REPLACED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED; DEVICE REGISTRATION SYSTEM INDICATES LIORESAL. NO SYMPTOMS OR OUTCOME WERE REPORTED. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.
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 | EXPLANTED| IMPLANTED| EXPLANTED| PROGRAMMER 8840 LOT# UNK| CATHETER MODEL 8709 LOT# N089646034| CATHETER MODEL 8709 LOT# N102941022| IMPLANTED |