FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2160937
·
Received June 16, 2011
Report
- Report Number
- 3004209178-2011-04477
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- May 1, 2011
- Report Date
- May 18, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE HCP SUSPECTED THAT THE CATHETER MAY HAVE FRACTURED. AN MRI WAS PLANNED TO TRY AND DETERMINE WHERE THE TIP OF THE CATHETER WAS. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL 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 | 52 YR | IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# N199028014 |