FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2062833
·
Received March 25, 2011
Report
- Report Number
- 3004209178-2011-02112
- Event Type
- Malfunction
- Date Received
- March 25, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 9, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A CONFIRMED CRITICAL ALARM DUE TO A MOTOR STALL HAD OCCURRED. THE PT EXPERIENCED AN UNDERDOSE AND FEELING ILL. IT WAS UNK IF THE SYMPTOMS WERE UNDERDOSE/ WITHDRAWAL OR IF THE PT GOT ILL FROM FOOD. THE PT WAS BEING TREATED WITH ORAL MEDICATIONS. AT THE TIME OF THE EVENT, THE PT WAS TRAVELING IN (B)(6). THE PUMP WAS USED TO DELIVER DILAUDID AND BUPIVICAINE. 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 | 48 YR | IMPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8578, LOT# N137747| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N134715001 |