FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1920063
·
Received December 3, 2010
Report
- Report Number
- 3007566237-2010-10171
- Event Type
- Injury
- Date Received
- December 3, 2010
- Date of Event
- November 23, 2010
- Report Date
- November 24, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS SEEN FOR A PUMP ADJUSTMENT. ABOUT AN HOUR AFTER LEAVING THE OFFICE, THE PT BECAME LETHARGIC. THE PT WAS TRANSPORTED TO THE HOSPITAL VIA AMBULANCE AND ADMITTED TO THE INTENSIVE CARE UNIT. THE PT WAS INTUBATED WITH A VENTILATOR ASSISTING RESPIRATIONS. SOME TIME AFTER THE PT'S ARRIVAL TO THE HOSPITAL, THE DOSE WAS DECREASED. PER THE HOSPITAL PHYSICIAN, A 1500% DOSE INCREASE HAD HAPPENED AT THE TIME OF THE DOSE ADJUSTMENT. THE PUMP WAS USED TO DELIVER DILAUDID, CLONIDINE AND BUPIVICAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Hospitalization| L| R | CATHETER: MODEL 8731SC, LOT# N147672001| EXPLANTED:| PROGRAMMER: MODEL 8840, LOT# UNK| IMPLANTED: |