FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1972411
·
Received January 24, 2011
Report
- Report Number
- 3004209178-2011-00576
- Event Type
- Injury
- Date Received
- January 24, 2011
- Date of Event
- January 10, 2011
- Report Date
- January 18, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ON (B)(6) 2011, THE HCP (HEALTHCARE PROFESSIONAL) ADDED A MORPHINE/BACLOFEN MIXTURE TO THE PUMP. ON (B)(6) 2011, THE PT EXPERIENCED VOMITING, SWEATING AND HEADACHES. ON (B)(6) 2011, THE PT STOPPED BREATHING. THE 911 WAS CALLED AND NARCAN INJECTION WAS ADMINISTERED. THE PT WAS SUBSEQUENTLY HOSPITALIZED AND RECEIVED IV (INTRAVENOUS) NARCAN INFUSION. THE MORPHINE WAS REMOVED FROM THE PUMP. THE PUMP WAS PROGRAMMED TO DELIVER BACLOFEN AT A SIMPLE CONTINUOUS RATE. THE IV NARCAN WAS TO INFUSE UNTIL THE MORPHINE "MOVES THROUGH THE DEVICE." ON (B)(6) 2011, IT WAS REPORTED THE PT RECOVERED WITH "NO ISSUES." ADD'L INFO 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 | 46 YR | Hospitalization| L | IMPLANTED:| CATHETER: MODEL 8709, LOT# N195545008| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8596SC, LOT# N197136003| EXPLANTED: |