FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 1990839
·
Received February 8, 2011
Report
- Report Number
- 6000030-2011-00976
- Event Type
- Injury
- Date Received
- February 8, 2011
- Date of Event
- March 25, 2004
- Report Date
- January 14, 2011
- Manufacturer
- RICE CREEK MFG
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT FOLLOWING THE CATHETER REVISION THE OUTCOME WAS NOTED AS RESOLVED WITHOUT SEQUELAE ON (B)(4) 2004.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CATHETER HAD DISLODGED FROM THE INTRATHECAL SPACE. THE PT EXPERIENCED INCREASED PAIN WITHOUT RESPONSE TO AGGRESSIVE ORAL AND INTRATHECAL OPIATES AND LOCAL ANESTHETICS. AN UNSPECIFIED SURGICAL INTERVENTION WITH THE CATHETER WAS PERFORMED. ON (B)(6) 2004, THE PT EXPIRED DUE TO ILLNESS. CAUSE OF DEATH WAS UNRELATED TO THE IMPLANTED SYSTEM. PER THE REPORTER, THE PT HAD CANCER. THE PUMP WAS USED TO DELIVER HYDROMORPHONE, TETRACAINE, CLONIDINE, BACLOFEN AND KETAMINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | RICE CREEK MFG | 8627L18 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention | IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709AA, LOT# J11708R23| IMPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT# UNK| EXPLANTED:| CATHETER: MODEL 8709AA, LOT# J11638R33 |