FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3103097
·
Received May 9, 2013
Report
- Report Number
- 3004209178-2013-07459
- Event Type
- Injury
- Date Received
- May 9, 2013
- Report Date
- May 7, 2013
- 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
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8709SC,SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A CATHETER FRACTURE OF THE DISTAL SEGMENT. THE PATIENT HAD PRESENTED WITH WITHDRAWAL PHENOMENA OF ITCHING AND SPASMS. AN X-RAY WAS PERFORMED ON (B)(6) 2013. THERE WAS NO HOSPITALIZATION AND THE PATIENT RECOVERED WITHOUT SEQUELA. THE PATIENT WANTED THE CATHETER FIXED, BUT THE SURGEON WAS UNWILLING TO REPLACE IT. THE SYSTEM WAS INFUSING LIORESAL. THIS INFORMATION WAS PREVIOUSLY REPORTED IN MANUFACTURER REPORT #3004209178-2013-07312, THOUGH UPON FURTHER REVIEW IT WAS SUSPECTED THAT THIS WAS A SEPARATE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 202871 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |