FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1936181
·
Received December 14, 2010
Report
- Report Number
- 3004209178-2010-10438
- Event Type
- Injury
- Date Received
- December 14, 2010
- Date of Event
- December 5, 2010
- Report Date
- December 5, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED RESPIRATORY DEPRESSION AND WAS IN THE INTENSIVE CARE UNIT. THE MANAGING HCP PRESCRIBED A DAILY DOSE DECREASE OF INTRATHECAL MORPHINE FROM 3.5 MG TO 2.0 MG/DAY. THE PT WAS STABLE AT THE TIME OF THIS REPORT. THEY WILL ASSESS THE PT'S CONDITION FOLLOWING THE DAILY DOSE DECREASE. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Hospitalization| L | CATHETER: MODEL 8711, LOT# N147112011| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 8840, LOT# UNKNOWN |