FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1851113
·
Received September 30, 2010
Report
- Report Number
- 3004209178-2010-07485
- Event Type
- Injury
- Date Received
- September 30, 2010
- Date of Event
- September 2, 2010
- Report Date
- September 2, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED (B)(6)2010 AND THREE DAYS AFTER IMPLANT, THERE WAS A CATHETER MIGRATION FROM TH10 TO TH11 WHICH WAS CONFIRMED BY X-RAY. THE CATHETER WAS RE-IMPLANTED ON (B)(6)2010. THE DOCTOR COMMENTED THAT THE CAUSE WAS UNKNOWN, BUT THE CATHETER LOOP OCCURRED IN THE MUSCLE MEMBRANE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, 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 | 8637 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Unknown | Required Intervention | CATHETER: MODEL 8711, LOT# N230691005.| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8711, LOT# N230691005 |