FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1828736
·
Received September 2, 2010
Report
- Report Number
- 3004209178-2010-06688
- Event Type
- Injury
- Date Received
- September 2, 2010
- Date of Event
- January 1, 2010
- Report Date
- August 5, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A CATHETER REVISION OR REPLACEMENT WAS DONE. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. PLEASE REFER TO MANUFACTURER REPORT # 6000030-2008-00968.
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 | 37 YR | CATHETER: MODEL 8709, LOT # N101984022| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT # N134721014| EXPLANTED:| PROGRAMMER: MODEL 8840, LOT # UNK| EXPLANTED:| IMPLANTED: |