FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 4242146
·
Received November 11, 2014
Report
- Report Number
- 3004209178-2014-21275
- Event Type
- Injury
- Date Received
- November 11, 2014
- Date of Event
- March 5, 2014
- Report Date
- October 17, 2014
- 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
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD PAIN IN THEIR PUMP POCKET. THE PATIENT REPORTED THAT THE PUMP SOMETIMES FLIPPED INSIDE OF THE POCKET. INTERVENTION INCLUDED SURGICAL REPOSITIONING ON (B)(6) 2014, THE PUMP WAS REMOVED FROM THE RIGHT LOWER QUADRANT AND RELOCATED TO RIGHT ANTERIOR THIGH. THERE WERE NO DIAGNOSTIC METHODS DONE. THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2014. IT WAS REPORTED THAT IT WAS UNLIKELY RELATED TO THE THERAPY OR DEVICE, BUT POSSIBLY RELATED TO THE IMPLANT PROCEDURE. THERE WERE NO FURTHER SIGNS OR SYMPTOMS. THE SEVERITY WAS REPORTED AS MILD. THE PUMP SYSTEM WAS DELIVERING BACLOFEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 725464 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MDT PUERTO RICO OPERATIONS CO | 8637-20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00052 YR | Required Intervention |