FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1822417
·
Received August 26, 2010
Report
- Report Number
- 3004209178-2010-06465
- Event Type
- Injury
- Date Received
- August 26, 2010
- Date of Event
- July 1, 2010
- Report Date
- July 26, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE SYSTEM WAS REMOVED AS THE CATHETER PLACEMENT WAS NOT IN THE PROPER PLACE. THE PT RECOVERED WITH SEQUELA. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
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 | 45 YR | Required Intervention | CATHETER: MODEL 8731SC, LOT# N142963026| EXPLANTED:| IMPLANTED: |