FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1211066
·
Received October 24, 2008
Report
- Report Number
- 2182207-2008-06859
- Event Type
- Injury
- Date Received
- October 24, 2008
- Date of Event
- September 1, 2008
- Report Date
- September 25, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PT DEVELOPED AN INFECTION AT THE PUMP POCKET SITE APPROXIMATELY TWO WEEKS AFTER IMPLANT. NO PATIENT SYMPTOMS WERE REPORTED. THE PT WAS ADMITTED TO THE HOSP. CULTURES WERE DONE AND WERE MRSA POSITIVE. IV ANTIBIOTICS WERE ADMINISTERED. THE PT'S FOLLOWING PHYSICIAN WAS NOT REACHABLE. THE HOSPITAL PHYSICIAN WAS PLANNING TO INTERROGATE THE PUMP TO SEE WHAT MEDICATION THE PT WAS RECEIVING VIA THE PUMP. ADDITIONAL INFO HAS BEEN REQUESTED BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 8637 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8840| CATHETER: MODEL 8709SC |