FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2140940
·
Received June 21, 2011
Report
- Report Number
- 3004209178-2011-04613
- Event Type
- Injury
- Date Received
- June 21, 2011
- Date of Event
- May 1, 2011
- Report Date
- May 26, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - 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 THAT THE PATIENT WAS NOT RECEIVING ADEQUATE PAIN RELIEF. ROTOR AND DYE STUDIES WERE PERFORMED; DATE AND RESULTS WERE NOT REPORTED. THE PUMP AND CATHETER WERE REPLACED. THERE WAS NO PATIENT INJURY, THE PATIENT RECOVERED WITHOUT SEQUELA. THE PUMP WAS USED TO DELIVER MORPHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Male | Required Intervention | CATHETER: MODEL 8709, LOT# J12475R32.| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J12475R32 |