FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2914181
·
Received January 14, 2013
Report
- Report Number
- 3004209178-2013-00556
- Event Type
- Injury
- Date Received
- January 14, 2013
- Report Date
- December 20, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER. (B)(4).
Description of Event or Problem · 1
THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT WITH SYMPTOMS OF INCREASED PAIN AND SPASMS. THE CATHETER WAS FOUND TO HAVE MIGRATED. ON (B)(6) 2012, THE PATIENT WAS TAKEN TO SURGERY AND THE CATHETER WAS SPLICED. THE SEVERITY OF THE EVENT WAS NOTED AS "MILD." THE PATIENT RECOVERED WITH SEQUELA OF UNCONTROLLED NAUSEA ON (B)(6) 2012. THE DEVICE SYSTEM WAS DELIVERING DILAUDID AND BACLOFEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 20730 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00042 YR | Required Intervention |