FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2235116
·
Received August 24, 2011
Report
- Report Number
- 3004209178-2011-06797
- Event Type
- Injury
- Date Received
- August 24, 2011
- Date of Event
- August 3, 2011
- Report Date
- August 3, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
HCP (HEALTH CARE PROVIDER) REPORTED THAT THE PT "APPEARED OVER-SEDATED AND THE PHYSICIAN ORDERED THE PUMP TO BE STOPPED". NO FURTHER INFO WAS PROVIDED. THE PUMP INFUSED MORPHINE 25 MG/ML AT THE DAILY DOSE OF 1.2 MG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Other | IMPLANTED:| EXPLANTED:| EXPLANTED:| UNK CONVERSION TYPE: MODEL 8590-9, LOT# N264718| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N270103005 |