FDA Adverse Event
Injury
Summary report: N
SYNCHROMED
MDR report key: 1132636
·
Received August 22, 2008
Report
- Report Number
- 2182207-2008-05172
- Event Type
- Injury
- Date Received
- August 22, 2008
- Date of Event
- July 23, 2008
- Report Date
- July 23, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A REFILL THE MEDICATION WAS PUT IN THE PT'S "BELLY" RATHER THAN THE PUMP RESERVOIR. AN AMBULANCE WAS CALLED AND THE PT WAS TAKEN AWAY. NO PT SYMPTOMS, TREATMENT, OR OUTCOME WAS REPORTED. THE PT'S PUMP CONTAINED MORPHINE SULFATE AND FENTANYL. ADD'L INFO HAS BEEN REQUESTED FROM THE HEALTHCARE PROVIDER, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED | LKK | MEDTRONIC NEUROMODULATION | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | CATHETER MODEL UNK LOT # UNK| EXPLANTED| IMPLANTED| PROGRAMMER MODEL UNK LOT # UNK |