FDA Adverse Event
Injury
Summary report: N
SYNCHROMED
MDR report key: 1420873
·
Received July 23, 2009
Report
- Report Number
- 2182207-2009-05114
- Event Type
- Injury
- Date Received
- July 23, 2009
- Date of Event
- February 25, 2009
- Report Date
- June 26, 2009
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SEE SCANNED PAGES.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN OVERDOSE AND INTOXICATION WITH DRUG WAS SUSPECTED. IT WAS LATER REPORTED THAT THE PT HAD BEEN TREATED WITH LIORESAL SINCE 2000. THE CURRENT PROGRAMMED DOSE WAS 512.5 MCG/DAY VIA INTRATHECAL PUMP. IN 2009, 50 MG OF BACLOFEN WAS ACCIDENTLY ADMINISTRATED AT ONE TIME VIA THE BOLUS PORT OF THE PUMP SYSTEM. SUBSEQUENTLY, THE PT EXPERIENCED UNCONSCIOUSNESS, RESPIRATORY INSUFFICIENCY, AND A QUESTIONABLE EPILEPTIC SEIZURE. LIORESAL TREATMENT WAS INTERRUPTED AND RE-INITIATED AFTER IMPROVEMENT OF THE PT'S CONDITION. THE EVENTS LED TO HOSPITALIZATION AND LASTED FOR A DURATION OF APPROX 7 DAYS. AFTER THE SYMPTOMS HAD RESOLVED, THERE WERE NO RESIDUAL DAMAGES.
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 | 41 YR | Hospitalization| L| R | EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL PROGRAMMER| CATHETER: MODEL CATHETER |