FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2230751
·
Received August 23, 2011
Report
- Report Number
- 3004209178-2011-06725
- Event Type
- Injury
- Date Received
- August 23, 2011
- Date of Event
- July 5, 2011
- Report Date
- April 28, 2016
- 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
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
A CATHETER BREAK WAS REPORTED. BOTH THE PUMP AND THE CATHETER WERE REPLACED. IT WAS STATED THAT THE PATIENT WENT THROUGH "CATHETER TROUBLES SEVEN TIMES".
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 | NA | Male | Required Intervention | "SEE H10...."| CATHETER: MODEL 8711, LOT# N280702002| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8711, LOT# N280702002 |