FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1840748
·
Received September 17, 2010
Report
- Report Number
- 3007566237-2010-07091
- Event Type
- Malfunction
- Date Received
- September 17, 2010
- Date of Event
- January 1, 2010
- Report Date
- August 20, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT IT WAS DIFFICULT TO FILL A PUMP'S RESERVOIR. THE RESERVOIR WAS ABLE TO BE ASPIRATED. USING A 10 ML SYRINGE, A NURSE WAS ABLE TO UNLOCK THE RESERVOIR BY AGGRESSIVELY PUSHING SALINE, HOWEVER, IT BECAME MORE DIFFICULT TO FILL. ATTEMPTING TO FILL THE RESERVOIR WAS EVENTUALLY STOPPED, AND THE PUMP WAS UPDATED ACCORDINGLY. IT WAS NOTED THAT A LATERAL X-RAY MAY BE ACQUIRED AT THE NEXT REFILL IF NEEDED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFO IS BEING REQUESTED FROM THE HCP, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | EXPLANTED:| CATHETER: MODEL 8709, LOT# N059707022| IMPLANTED: |