FDA Adverse Event
Injury
Summary report: N
SYNCHROMED
MDR report key: 2063782
·
Received April 15, 2011
Report
- Report Number
- 3007566237-2011-02842
- Event Type
- Injury
- Date Received
- April 15, 2011
- Report Date
- April 2, 2011
- 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
WHEN THE PHYSICIAN WAS REPORTING ANOTHER EVENT, HE MENTIONED ANOTHER PATIENT THAT HAD OVERDOSE SYMPTOMS FOLLOWING A DYE STUDY IN THE PAST. IN FOLLOW-UP, THE PHYSICIAN STATED THAT "HE DID NOT REMEMBER MENTIONING ANY OTHER PATIENTS." THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN.
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 | Other | CATHETER: MODEL CATHETER, LOT# UNKNOWN| IMPLANTED:| PROGRAMMER: MODEL 8840, LOT# UNKNOWN| EXPLANTED: |