FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1040040
·
Received May 7, 2008
Report
- Report Number
- 2182207-2008-02431
- Event Type
- Injury
- Date Received
- May 7, 2008
- Date of Event
- January 1, 2007
- Report Date
- April 8, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PT EXPERIENCED A POST OPERATIVE INFECTION OF STAPH AUREUS. THE DRUG IN THE PUMP WAS LIORESAL INTRATHECAL. NO CONCENTRATION OR DOSE WERE REPORTED. THE PUMP WAS EXPLANTED IN 2007. NO OTHER SYMPTOMS WERE REPORTED. THE PT RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED:| CATHETER MODEL 8711 LOT# N109238011 |