FDA Adverse Event Injury Summary report: N

SYNCHROMED II

MDR report key: 2190702 · Received July 26, 2011

Report

Report Number: 3007566237-2011-05782
Event Type: Injury
Date Received: July 26, 2011
Date of Event: July 1, 2011
Report Date: July 6, 2011
Manufacturer: MEDTRONIC NEUROMODULATION
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KS, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

Description of Event or Problem · 1

IT WAS INITIALLY REPORTED THAT A CRITICAL ALARM WAS HEARD, AND CONFIRMED VIA TELEMETRY. THE PUMP RESET AND WENT INTO SAFE STATE ON (B)(6) 2011, FOLLOWING AN ATTEMPTED PROGRAMMING OF A PRIME BOLUS. A "NO BOLUS MODE" MESSAGE WAS ACKNOWLEDGED FOLLOWING THE ALARM. LOW BATTERY AND MOTOR STALL WERE ALSO INDICATED. THE PT HAD WITHDRAWAL SYMPTOMS THAT WERE BEING MANAGED BY A PHYSICIAN. THE PUMP INFUSED LIORESAL 2000 MCG/ML AT 12.3 MCG/DAY. IT WAS LATER REPORTED THAT THE PUMP COULD NOT BE RESET FOLLOWING THE SAFE STATE. THE PUMP'S ELECTIVE REPLACEMENT INDICATOR STATED 15 MONTHS. THE PUMP WAS REPLACED. THE PT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELA.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SYNCHROMED II		LKK	MEDTRONIC NEUROMODULATION	863720	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	44 YR		Required Intervention	CATHETER: MODEL 8731, LOT # N056264008\| EXPLANTED:\| IMPLANTED: