FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED
MDR report key: 1884836
·
Received October 15, 2010
Report
- Report Number
- 3007566237-2010-08003
- Event Type
- Malfunction
- Date Received
- October 15, 2010
- Date of Event
- September 20, 2010
- Report Date
- September 20, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LENGTH OF THE GUIDE WIRE WAS SHORTER THAN THE NORMAL SIZE AND THE SURGEON COULD NOT INSERT THE NEEDLE THROUGH THE CATHETER. THE GUIDEWIRE WAS STERILIZED AFTER REMOVAL AND THE SURGEON IMPLANTED A NEW CATHETER. THE DRUG, DOSAGE AND CONCENTRATION WERE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE MADE AS FOLLOW UP AS IT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED | LKK | MEDTRONIC NEUROMODULATION | PUMP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CATHETER ACCESSORY: MODEL 8709, LOT# N182610008| IMPLANTED:| EXPLANTED: |