FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2032465
·
Received March 25, 2011
Report
- Report Number
- 3004209178-2011-02318
- Event Type
- Injury
- Date Received
- March 25, 2011
- Report Date
- March 10, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED 'NO EFFICACY DESPITE MULTIPLE TITRATION ATTEMPTS ON HIS BACLOFEN PUMP". THE PT UNDERWENT A ROLLER STUDY AND CATHETER DYE STUDY; THE DATE WAS UNSPECIFIED. BOTH TESTS WERE REPORTED AS BEING UNREMARKABLE. THE DEVICE SYSTEM WAS EXPLANTED AND REPLACED. A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED:| CATHETER: MODEL 8731SC, LOT# N257594002| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N262601003| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 8590-1, LOT# N198972| EXPLANTED: |