FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2220227
·
Received August 16, 2011
Report
- Report Number
- 3004209178-2011-06400
- Event Type
- Injury
- Date Received
- August 16, 2011
- Date of Event
- July 1, 2011
- Report Date
- July 21, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
A CATHETER "DROP OFF" WAS REPORTED. THE CATHETER WAS REPLACED. AT THE REPLACEMENT, DR FOUND OUT THE V-WING ANCHOR WAS BROKEN. THE DRUG DELIVERED WAS GABALON (BACLOFEN).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention | CATHETER: MODEL 8711, LOT# N246491005.| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8711, LOT# N246491005 |