FDA Adverse Event
Death
Summary report: N
SYNCHROMED EL
MDR report key: 1650576
·
Received April 1, 2010
Report
- Report Number
- 6000030-2010-02681
- Event Type
- Death
- Date Received
- April 1, 2010
- Report Date
- March 8, 2010
- 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
Additional Manufacturer Narrative · 1
(B) (4) - THE PUMP HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD EXPIRED. THE PT'S CAUSE OF DEATH AND THE RELATIONSHIP OF THE IMPLANTED DEVICE TO THE PT'S DEATH WERE NOT REPORTED. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.
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 | Death | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# L64339| PROGRAMMER: MODEL PROGRAMMER, LOT# UNK |