SYNCHROMED II

Report

Report Number: 2182207-2008-07427
Event Type: Injury
Date Received: November 13, 2008
Date of Event: October 17, 2008
Report Date: October 18, 2008
Manufacturer: MEDTRONIC NEUROMODULATION
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS, WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT, WHEN THE ANALYSIS IS COMPLETE.

Description of Event or Problem · 1

TELEMETRY CONFIRMED THAT A CRITICAL ALARM WAS OCCURRING. THE PUMP SHOWED A RESET DUE TO A LOW BATTERY ALARM AND WAS IN "SAFE STATE". THE PATIENT EXPERIENCED TWITCHING AND DROWSINESS, AND WAS GIVEN ATIVAN IN THE EMERGENCY ROOM. THE PUMP HAD BEEN REFILLED THE PREVIOUS DAY, SO THE EMERGENCY ROOM PHYSICIAN RESET THE PUMP TO THE LAST SETTINGS CHARTED FROM THE PREVIOUS DAYS REFILL. THE PATIENT WAS KEPT OVERNIGHT IN A MONITORED BED. THE PATIENT WAS GIVEN A PRESCRIPTION FOR ORAL BACLOFEN. WHEN THE MANAGING PHYSICIAN SAW THE PATIENT, THE PATIENT 'LOOKED FINE'. THE PUMP CONTINUED TO ALARM EVERY 10 MINUTES PER THE CRITICAL ALARM SETTING, BUT INDICATED 'NO ALARM'. A REVISION WAS PERFORMED AND AT THAT TIME THE PUMP WAS ALARMING. THERE WAS NO DIALOGUE BOX INDICATING WHICH ALARM WAS OCCURRING AND NO LOG STATING THAT AN ALARM WAS OCCURRING. THE PUMP WAS USED TO DELIVER LIORESAL 2000MCG/ML. THE PATIENT'S OUTCOME WAS REPORTED AS NO INJURY; RECOVERED WITHOUT SEQUELA. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SYNCHROMED II		LKK	MEDTRONIC NEUROMODULATION	863740	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R	EXPLANTED:\| IMPLANTED:\| CATHETER: MODEL 8709\| PROGRAMMER: MODEL 8840