FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3002886
·
Received March 13, 2013
Report
- Report Number
- 3004209178-2013-03680
- Event Type
- Injury
- Date Received
- March 13, 2013
- Report Date
- February 13, 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE CATHETER. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS LATER REPORTED THAT THE PATIENT CONTINUED TO DO FINE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THIS PATIENT HAD BEEN IN A CAR ACCIDENT AND THE CATHETER WAS DISLODGED FROM THE INTRATHECAL SPACE. A NEW CATHETER SEGMENT WAS SUCCESSFULLY IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. THIS DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN.
Description of Event or Problem · 1
IT WAS LATER REPORTED THAT THE REMAINING CATHETER WAS NOT ASPIRATED BECAUSE IT WAS NOT IN USE ANYMORE. THE PATIENT¿S SYMPTOMS INCLUDED AN INCREASE IN TONE. THE PATIENT WAS DOING WELL AND THEIR THERAPY WAS EFFECTIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105473 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |