FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 1081278
·
Received July 24, 2008
Report
- Report Number
- 6000030-2008-04363
- Event Type
- Injury
- Date Received
- July 24, 2008
- Date of Event
- April 1, 2000
- Report Date
- June 27, 2008
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE PT'S PUMP WAS IMPLANTED, THE DOCTOR HIT A NERVE AND THE PT CAN ONLY VOID HIS BLADDER ONCE A DAY. THE PT ALSO HAS A LIMP. NO PT TREATMENT OR OUTCOME WAS REPORTED. 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 EL | LKK | RICE CREEK MANUFACTURING | 8627L18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Disability | PROGRAMMER MODEL PORGRAMMER LOT# UNK| EXPLANTED:| IMPLANTED:| CATHETER MODEL 8709 LOT #L78693 |