FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1843563
·
Received September 22, 2010
Report
- Report Number
- 3004209178-2010-07191
- Event Type
- Injury
- Date Received
- September 22, 2010
- Date of Event
- August 18, 2010
- Report Date
- August 20, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT DEVELOPED AN INFECTION. THE PUMP WAS REMOVED WITHOUT MANUFACTURER SUPPORT. THE PUMP CONTAINED MORPHINE; THE DOSAGE AND CONCENTRATION WERE UNK. PT'S STATUS WAS UNAVAILABLE AT THE TIME OF REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE MADE AS F/U AS IT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention | IMPLANTED:| CATHETER: MODEL 8703W, LOT# L36317| EXPLANTED:| CATHETER: MODEL 8596SC, LOT# N247402014| EXPLANTED:| IMPLANTED: |