FDA Adverse Event
Injury
Summary report: N
UNKNOWN
MDR report key: 1021080
·
Received March 27, 2008
Report
- Report Number
- 2182207-2008-01635
- Event Type
- Injury
- Date Received
- March 27, 2008
- Report Date
- February 26, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THAT A DAY AND A HALF AFTER A REFILL AND UNSPECIFIED DRUG CHANGE THE PT WENT TO THE ER AND WAS ADMITTED TO THE HOSPITAL FOR A DRUG OVERDOSE (UNSPECIFIED SYMPTOMS). THE PT WAS RELEASED FOUR DAYS LATER. THE PT OUTCOME WAS REPORTED AS FAIR. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN | LKK | MEDTRONIC NEUROMODULATION | PROGRAMMER | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | IMPLANTED:| EXPLANTED:| CATHETER MODEL 8709| IMPLANTABLE INFUSION PUMP MODEL 8627L18| IMPLANTED:| LOT# NGH046525R| EXPLANTED: |