FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 2143054
·
Received June 23, 2011
Report
- Report Number
- 3007566237-2011-04687
- Event Type
- Injury
- Date Received
- June 23, 2011
- Report Date
- May 27, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD NUMBNESS IN BOTH OF HER LEGS. THE PT EXPERIENCED AN OVERDOSE AROUND THE TIME OF AN UNRELATED MEDICAL PROCEDURE, BUT WASN'T CLEAR ON WHETHER OR NOT THE OVERDOSE WAS RELATED TO MEDICATION FROM HER PUMP OR OTHER MEDICATIONS SHE WAS TAKING. THE PT WAS ADMITTED TO THE HOSPITAL AND WAS CONCERNED THAT HER "PUMP MIGHT NOT BE WORKING." ADD'L INFO HAS BEEN REQUESTED; BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
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 | Hospitalization | UNK: MODEL UNK, LOT# *UK6148248| EXPLANTED:| IMPLANTED: |