FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 1051677
·
Received May 21, 2008
Report
- Report Number
- 6000030-2008-02712
- Event Type
- Injury
- Date Received
- May 21, 2008
- Date of Event
- March 2, 2008
- Report Date
- July 14, 2014
- Manufacturer
- RICE CREEK MANUFACTURING
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-0956-2008
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED BODY TREMBLING, SWEATING, AND SHORTNESS OF BREATH. THE PT ALSO FELT LIKE HE WAS BURNING UP BUT HIS BODY WAS COOL TO THE TOUCH AND HE HAD NO FEVER. THE PT WAS TAKEN TO THE ER AND THEN ADMITTED TO THE HOSP. HIS STATUS WAS REPORTED AS "FAIR." THE CONCENTRATION AND DAILY DOSE OF BACLOFEN BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL 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 | 53 YR | Male | Hospitalization| R | CATHETER MODEL 8709 LOT # L58361 IMPLANTED| EXPLANTED| PROGRAMMER MODEL PROGRAMMER LOT # UNK| CATHETER MODEL 8709 LOT # L58361 IMPLANTED| EXPLANTED| PROGRAMMER MODEL PROGRAMMER LOT # UNK |