FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED
MDR report key: 2152292
·
Received June 23, 2011
Report
- Report Number
- 3007566237-2011-04732
- Event Type
- Malfunction
- Date Received
- June 23, 2011
- Date of Event
- May 1, 2001
- Report Date
- May 27, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED WITHDRAWAL. THE WITHDRAWAL OCCURRED AFTER A DOSE DECREASE FOLLOWING A REVISION. THE REPORTER PLANNED ON TREATING THE PATIENT WITH BENZODIAZEPINES AND TO INCREASE THE DOSAGE OF MEDICATION. THE DRUG IN PUMP AT THE TIME OF THE EVENT WAS BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
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 |