FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1032143
·
Received April 21, 2008
Report
- Report Number
- 2182207-2008-02123
- Event Type
- Injury
- Date Received
- April 21, 2008
- Report Date
- March 22, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE SYS WAS REMOVED DUE TO INFECTION. PT SYMPTOMS INCLUDED REDNESS, DRAINAGE, AND INCISIONAL WOUND OPENING. THE PRIMARY LOCATION OF THE INFECTION WAS THE DEVICE POCKET, BUT IT IS UNK IF A CULTURE WAS OBTAINED. THE PT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS AND THE INFECTION RESOLVED. THE PT DIDN'T DEVELOP MENINGITIS AND HAD BEEN GIVEN PERIOPERATIVE ANTIBIOTICS. THE TYPE OF MEDICATION ADMINISTERED BY THE PUMP WAS COMPOUND BACLOFEN. THE PT IS "DOING MUCH BETTER OFF INTRATHECAL OPIOIDS."
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 | CATHETER MODEL 8709 LOT#L81438| EXPLANTED| IMPLANTED| PROGRAMMER MODEL 8840 LOT# UNK |