FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1844591
·
Received September 23, 2010
Report
- Report Number
- 3007566237-2010-07211
- Event Type
- Injury
- Date Received
- September 23, 2010
- Date of Event
- April 1, 2010
- Report Date
- April 20, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT HAD A PROBLEM WITH A CATHETER. IT WAS STATED THAT "POOLING" OF DYE OCCURRED NEAR THE CATHETER ANCHOR. A REVISION WAS PERFORMED, DURING WHICH ONE OR MORE HOLES WERE FOUND IN THE CATHETER NEAR THE ANCHOR. THE SPINAL SECTION OF THE CATHETER WAS REVISED AND CONNECTED TO THE EXISTING CATHETER. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT 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 | 49 YR | Required Intervention | CATHETER: MODEL 8709, LOT#: J10996R57| IMPLANTED:| EXPLANTED: |