FDA Adverse Event Malfunction Summary report: N

2182208-2012-03790

MDR report key: 2812925 · Received October 31, 2012

Report

Report Number: 2182208-2012-03790
Event Type: Malfunction
Date Received: October 31, 2012
Date of Event: October 8, 2012
Manufacturer: MEDTRONIC, INC.
Product Code: DPS
PMA / PMN Number: K024278
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE MODULE WAS "NOT WORKING." THE CLIENT INDICATED THERE WAS "HORRIBLE NOISE" DURING REAL TELEMETRY. ALSO NOTED WAS THAT THERE WERE NO EKG STRIPS BEING CAPTURED. THE CLIENT HAS CHANGED THE COMPUTER, CABLES, MODULES AND STILL HAS A "FUZZY BASELINE PICTURE." FURTHER INVESTIGATION BY TECHNICAL SERVICES (TS) INDICATED THROUGH A CONVERSATION WITH INFORMATION TECHNOLOGY (IT) REVEALED THAT THE PROGRAMMER IS LESS THAN ONE FOOT AWAY FROM THE MODULE IN THIS PARTICULAR ROOM. THEY ALSO DO NOT HAVE AN ISOLATION TRANSFORMER AND ARE RECORDING IN-CLINIC ELECTROCARDIOGRAMS (ECGS). IT STARTED ECG RECORDING IN A TEST PATIENT RECORD AND WHEN THE PROGRAMMER WAS TURNED ON THE WAVEFORM BECAME "VERY NOISY." TS COULD NOT REPLICATE ANY ERRORS AT THE TIME. TS SUGGESTED THEY MOVE THE PROGRAMMER FURTHER AWAY FROM THE MODULE AND POSSIBLY INSTALL AN ISOLATION TRANSFORMER. THE CLIENT WILL TRY THESE THINGS AND WILL CALL BACK IF THEY NEED FURTHER ASSISTANCE. NO PT COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1			DPS	MEDTRONIC, INC.	P127

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other