FDA Adverse Event
Death
Summary report: N
SYNCHROMED EL
MDR report key: 2844074
·
Received November 25, 2012
Report
- Report Number
- 6000030-2012-00211
- Event Type
- Death
- Date Received
- November 25, 2012
- Date of Event
- October 24, 2012
- Report Date
- October 26, 2012
- Manufacturer
- RICE CREEK MFG
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8709, LOT# J0039644R, IMPLANTED: (B)(6) 2000, EXPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT DIED. THE DEATH WAS UNRELATED TO THE IMPLANTED PUMP. THE PATIENT DIED OF OLD AGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | RICE CREEK MFG | 8627-18 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00097 YR | Death |