FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2964482
·
Received February 15, 2013
Report
- Report Number
- 3004209178-2013-02735
- Event Type
- Injury
- Date Received
- February 15, 2013
- Report Date
- January 28, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 8709SC SERIAL# (B)(4), IMPLANTED: 2011-(B)(6), PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED AN OVERDOSE. THE PATIENT WAS IN THE EMERGENCY ROOM UNRESPONSIVE. THE HEALTHCARE PROVIDER (HCP) SUSPECTED AN OVERDOSE AND HAD GIVEN THE PATIENT NARCAN WITH INCREASED POSITIVE CHANGE IN HIS LEVEL OF CONSCIOUSNESS. THE REPORTER DID NOT HAVE ANY FURTHER HISTORY OR DETAIL. THE HCP WAS CONTEMPLATING EMPTYING THE PUMP RESERVOIR TO FORCE A STOPPED PUMP. THE DRUG BEING DELIVERED VIA THE DEVICE WAS MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 69218 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |