FDA Adverse Event
Injury
Summary report: N
SYNCHROMED
MDR report key: 992405
·
Received February 6, 2008
Report
- Report Number
- 2182207-2008-00554
- Event Type
- Injury
- Date Received
- February 6, 2008
- Report Date
- August 23, 2007
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF EVENTS RELATED TO MEDTRONIC NEUROMODULATION OFFICE OF MEDICAL AFFAIRS EVENTS AND HAS BEEN DISCUSSED WITH THE REPORTING SYSTEMS MONITORING BRANCH AT FDA.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PEDIATRIC PT HAD THE PUMP REMOVED DUE TO INFECTION. NO OTHER INFO WAS PROVIDED. FOLLOW-UP IS NOT POSSIBLE AS PT/DEVICE IDENTIFIERS WERE NOT PROVIDED AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED | LKK | MEDTRONIC NEUROMODULATION | PUMP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Hospitalization| R | PROGRAMMER MODEL PROGRAMMER| CATHETER MODEL CATHETER LOT# UNK| IMPLANTED:| EXPLANTED: |