FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3072852
·
Received April 23, 2013
Report
- Report Number
- 3004209178-2013-06749
- Event Type
- Injury
- Date Received
- April 23, 2013
- Report Date
- March 27, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROPHYLACTIC PUMP AND CATHETER EXPLANT DUE TO INFECTION. THE PUMP WAS IMPLANTED IN (B)(6) 2012 AND 'SHE WAS EXPLANTED AT SOME DATE FOR INFECTION AND SHE WAS RE-IMPLANTED TODAY.' NO SYMPTOMS WERE REPORTED. THE MEDICATION DELIVERED BY THE DEVICE SYSTEM WAS NOT PROVIDED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED, THE PATIENT WAS DOING WELL AND RECEIVING EFFECTIVE THERAPY AS OF (B)(6) 2013. THE PUMP WAS BEING USED TO DELIVER COMPOUNDED BACLOFEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 174239 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |