FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1171215
·
Received September 22, 2008
Report
- Report Number
- 6000030-2008-05991
- Event Type
- Injury
- Date Received
- September 22, 2008
- Date of Event
- September 3, 2008
- Report Date
- August 25, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THE PT HAD THE PUMP AND CATHETER REPLACED. THE PUMP WAS REPLACED PROPHYLACTICALLY TO AVOID IN-VIVO BATTERY DEPLETION. THE CATHETER WAS REPLACED DUE TO AN OCCLUSION. THE DRUG IN THE PUMP WAS MORPHINE AT A CONCENTRATION OF 14 MG/DL AND A DOSE OF 0.672 MG/DAY. NO SYMPTOMS WERE REPORTED. THE PT RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | RICE CREEK MANUFACTURING | 8627L18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention | EXPLANTED| CATHETER MODEL 8731 LOT# B007008N34| IMPLANTED| PROGRAMMER MODEL PROGRAMMER LOT# UNK |