FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 4102067
·
Received September 19, 2014
Report
- Report Number
- 3004209178-2014-17373
- Event Type
- Injury
- Date Received
- September 19, 2014
- Date of Event
- August 27, 2014
- Report Date
- August 27, 2014
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT: PRODUCT ID 8731SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED LOSS OF EFFECT OF OPIOD EFFECT. AN X-RAY AND CT WAS PERFORMED, DATES NOT REPORTED. THE CATHETER DISLODGED. THE CATHETER HAD GONE OUT OF THE INTRATHECAL SPACE AND DROPPED DOWN 2 LEVELS. A REVISION/REPLACEMENT WAS DONE. PER THE REPORTER THEY WERE NOT GETTING FLOW AND THEY USED OLD PUMP SEGMENT BUT REMOVED AND REPLACED THE CONNECTOR PIECE. NO CATHETER SEGMENTS WERE LEFT IN THE PATIENT OR THE INTRATHECAL SPACE. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT. THE PUMP WAS USED TO DELIVER MORPHINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 581667 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00052 YR | Required Intervention |