FDA Adverse Event
Injury
Summary report: N
SYNCHROMED EL
MDR report key: 1970158
·
Received January 14, 2011
Report
- Report Number
- 3007566237-2011-00369
- Event Type
- Injury
- Date Received
- January 14, 2011
- Date of Event
- December 21, 2010
- Report Date
- December 21, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED THAT THE PUMP WAS FILLED WITH A 2000 MCG/ML CONCENTRATION OF BACLOFEN; THE PUMP HAD PREVIOUSLY HAD 4000 MCG/ML. THE PHYSICIAN WAS NOT ABLE TO PERFORM A BRIDGE BOLUS BECAUSE THE MINIMUM DOSE DURING THE BRIDGE WAS HIGHER THAN WHAT THE PT WAS CURRENTLY GETTING. FOLLOWING THE REFILL, THE PT WAS REPORTED TO BE HAVING AN OVERDOSE; THE PT WAS GETTING SLEEPY. IT WAS REPORTED THAT THE PT CAME BACK TO THE OFFICE TO BE EVALUATED. IT WAS UNKNOWN IF ANY PROGRAMMING CHANGES WERE MADE. THE PHYSICIAN DID SAY "THE PT WAS FINE, NO ADVERSE REACTIONS." ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SENT, IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED EL | LKK | MEDTRONIC NEUROMODULATION | 8627 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | PROGRAMMER: MODEL 8840, LOT# UNK |