FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2183691
·
Received July 8, 2011
Report
- Report Number
- 3007566237-2011-05239
- Event Type
- Malfunction
- Date Received
- July 8, 2011
- Report Date
- June 16, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT RECOLLECTED THAT WITH HER PREVIOUS PHYSICIAN, SHE EXPERIENCED WITHDRAWAL SYMPTOMS BUT SHE WAS TOLD IT WAS THE "FLU". SHE ALSO STATED THAT AT HER REFILL SESSION, THE NURSE WITHDREW MORE DRUG THAN WHAT WAS EXPECTED. HOWEVER, SHE COULD NOT RECOLLECT THE DATE FOR THIS EVENT. CURRENTLY THE PT WAS AT HOME AND DEFINED HER STATUS TO BE "GOOD". HOWEVER, SHE WAS APPROACHING HER REFILL DATE AND DID NOT HAVE A MANAGING PHYSICIAN. HER PUMP REFILL ALARM DATE WAS SET FOR (B)(6) 2011 AND SHE WAS CONCERNED SHE WOULD RUN OUT OF DRUG BY THE WEEKEND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | CATHETER: MODEL 8709, LOT# L65383| IMPLANTED:| EXPLANTED: |