FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1822586
·
Received August 27, 2010
Report
- Report Number
- 3007566237-2010-06534
- Event Type
- Injury
- Date Received
- August 27, 2010
- Report Date
- July 30, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- 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 DURING A PUMP REFILL ON THE (B)(6) 2010, THE PUMP NEEDLE CAME OUT OF THE REFILL AND THE PUMP POCKET WAS FILLED WITH 17 ML OF 2MG/ML DILAUDID. PATIENT WENT INTO OVERDOSE SYMPTOMS, WAS DIAPHORETIC WITH CHEST WALL TIGHTNESS AND DIZZINESS. PT WAS HOSPITALIZED. WAS REFILLED (B)(6) 2010 WITH THE FULL VOLUME OF FLUID. THE PATIENT WAS REPORTED DOING WELL NOW.
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 | Hospitalization | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N144952017 |