FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2001555
·
Received January 26, 2011
Report
- Report Number
- 3004209178-2011-00641
- Event Type
- Injury
- Date Received
- January 26, 2011
- Report Date
- August 5, 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
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT'S PHYSICIAN WAS UNABLE TO PUSH ANY DYE INTO THE CATHETER DURING A CATHETER DYE STUDY. THE CATHETER WAS BELIEVED TO BE KINKED; THE CAUSE WAS UNK. THE PT HAS "NOT HAD A LOT OF RELIEF" DUE TO "CATHETER PROBLEMS." A CATHETER REVISION WAS PLANNED. THE MEDICATION BEING DELIVERED VIA THE DEVICE WAS LIORESAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-40 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Hospitalization| R | CATHETER MODEL 8709SC, LOT# N179828011| CATHETER: MODEL 8598A, LOT # N252380013| EXPLANT DATE: | EXPLANTED:| IMPLANT DATE: | IMPLANTED:| CATHETER: MODEL 8598A, LOT # N252380013| IMPLANTED:| EXPLANTED: |