FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1850926
·
Received September 29, 2010
Report
- Report Number
- 3007566237-2010-07430
- Event Type
- Injury
- Date Received
- September 29, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 1, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P86004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHORT LOSS OF CONSCIOUSNESS, BLURRED VISION, SYNCOPE AND LOSS OF FEELING IN THE UPPER EXTREMITIES. THE PUMP CONTAINED FENTANYL; DOSAGE AND CONCENTRATION UNK. 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 II | LGW | LKK | MEDTRONIC NEUROMODULATION | 8637-20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Disability | CATHETER: MODEL 8596SC, LOT# N237043001| IMPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8711, LOT# N229850004| EXPLANTED: |