FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3203509
·
Received July 2, 2013
Report
- Report Number
- 3004209178-2013-02999
- Event Type
- Injury
- Date Received
- July 2, 2013
- Report Date
- July 5, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2011-(B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8590-1, LOT# N263891, IMPLANTED: 2011-(B)(6). PRODUCT TYPE ACCESSORY. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT WAS NOT SATISFIED WITH THE LEVEL OF SPASTICITY RELIEF. IT WAS REPORTED THAT THE PATIENT WAS ¿GETTING TENSE¿ AND EXPERIENCED CONSTIPATION AND SEIZURES. WHEN THE DOSAGE IS INCREASED SHE ¿DOES BETTER¿. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302351 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |