FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1920123
·
Received December 8, 2010
Report
- Report Number
- 3004209178-2010-10331
- Event Type
- Injury
- Date Received
- December 8, 2010
- Date of Event
- December 1, 2010
- Report Date
- December 1, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PUMP WAS REFILLED. WITHIN 2 HOURS OF REFILL PROCEDURE, THE PT WAS COMATOSE. THE PT WAS TAKEN TO THE ER (EMERGENCY ROOM). THE PT RESPONDED TO NARCAN ADMINISTRATION. TROUBLESHOOTING OPTIONS INCLUDING STOPPING THE PUMP AND EMPTYING THE RESERVOIR WERE CONSIDERED. THE TYPE OF PUMP MEDICATION WAS NOT REPORTED. 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 |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Life Threatening| O | IMPLANTED:| CATHETER: MODEL 8709, LOT# J11308R15| EXPLANTED: |