FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2133557
·
Received June 15, 2011
Report
- Report Number
- 3007566237-2011-04440
- Event Type
- Injury
- Date Received
- June 15, 2011
- Date of Event
- March 30, 2011
- Report Date
- May 18, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DECREASED THERAPEUTIC BENEFIT. THE DIAGNOSIS OF THE CATHETER ISSUE WAS REPORTED AS UNKNOWN AT THE TIME OF THIS REPORT. A KUB X-RAY WAS PERFORMED ON (B)(6) 2011. THE RESULTS WERE NOT REPORTED. ON (B)(6) 2011, THE PATIENT HAD A CATHETER REVISION. ON (B)(6) 2011, THE PATIENT WAS "SLEEPY AND MUSCLE TONE WAS RATHER LOOSE." ON (B)(6) 2011, THE PATIENT WAS DOING WELL AND HAD HIS DOSAGE DECREASED SEVERAL TIMES OVER THE FIRST MONTH SINCE THE REVISION. THE DRUG IN THE PUMP AT THE TIME OF THE EVENT WAS LIORESAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Required Intervention | EXPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N281265006| IMPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8731SC, LOT# N180292020| CATHETER: MODEL 8596SC, LOT# N257566015 |