FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1852087
·
Received September 28, 2010
Report
- Report Number
- 3007566237-2010-07373
- Event Type
- Malfunction
- Date Received
- September 28, 2010
- Report Date
- September 1, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S HEALTHCARE PROVIDER (HCP) WAS ABLE TO ASPIRATE THE PT'S PUMP RESERVOIR, BUT UNABLE TO COMPLETELY FILL IT. THE HCP FILLED THE 40 ML PUMP RESERVOIR WITH APPROXIMATELY 35-36 ML OF MEDICATION. AT THAT POINT, THE HCP MET RESISTANCE IN ATTEMPTING TO FILL THE RESERVOIR FURTHER. THE HCP REMOVED THE MEDICATION AND FLUSHED THE RESERVOIR WITH APPROXIMATELY 10 ML OF SALINE. THE HCP ATTEMPTED TO REFILL THE RESERVOIR, BUT AGAIN, WAS ONLY ABLE TO FILL THE PUMP WITH APPROXIMATELY 35-36 ML. THERE WAS NO INFO PROVIDED REGARDING THE TYPE, CONCENTRATION OR DOSAGE OF MEDICATION USED IN THE PT'S PUMP. NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 8637 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | EXPLANTED:| CATHETER: MODEL CATHETER, LOT # UNK| IMPLANTED: |