FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1800581
·
Received August 12, 2010
Report
- Report Number
- 3007566237-2010-06072
- Event Type
- Injury
- Date Received
- August 12, 2010
- Date of Event
- July 1, 2010
- Report Date
- July 15, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT FOLLOWING A PUMP REPLACEMENT, THE PATIENT EXPERIENCED AN OVERDOSE WITH VOMITING AND A RESULTING COMA. THE PATIENT WAS ADMITTED TO THE HOSPITAL, WITH THE STATUS OF "UNKNOWN." NO FURTHER DETAILS, PATIENT'S SYMPTOMS OR OUTCOME WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED 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 | 12 YR | Hospitalization| R | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# J11385R65 |