FDA Adverse Event
Injury
Summary report: N
SYNCRHOMED II
MDR report key: 1902273
·
Received November 15, 2010
Report
- Report Number
- 3004209178-2010-09467
- Event Type
- Injury
- Date Received
- November 15, 2010
- Date of Event
- October 1, 2010
- Report Date
- October 29, 2010
- 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
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED TO HAVE THE PUMP REMOVED ON (B)(6) 2010. THE EXPLANT WAS PLANNED DUE TO AN ABSCESS ON THE PATIENT'S COCCYX, AND THE OPENING OF THE PUMP INCISION SITE THAT EXPOSED THE CATHETER. THE PLAN WAS TO REMOVE THE PATIENT'S ENTIRE SYSTEM, ALLOW THE INFLECTION TO RESOLVE, AND THEN REPLACE THE PATIENT'S SYSTEM. THERE WAS NO INFORMATION PROVIDED REGARDING THE TYPE, CONCENTRATION OR DOSAGE OF THE MEDICATION USED IN THE PATIENT'S PUMP. NO FURTHER DETAILS, PATIENT SYMPTOMS OR OUTCOME WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCRHOMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention | IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N261145008| PROGRAMMER: MODEL 8835, LOT# NPG017101N| IMPLANTED:| EXPLANTED:| EXPLANTED: |