PROTECTA XT VR

MDR report key: 2813087 · Received October 31, 2012

Report

Report Number: 6000144-2012-06466
Event Type: Injury
Date Received: October 31, 2012
Date of Event: October 9, 2012
Report Date: April 7, 2015
Manufacturer: MEDTRONIC MED REL, INC.
Product Code: LWS
PMA / PMN Number: P980016/S211
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS ADDITIONALLY REPORTED THAT THE DEVICE WAS UNABLE TO BE INTERROGATED. THERE WERE NO GREEN LIGHTS ON THE PROGRAMMER AND NO TONE. THE PATIENT HAS NOT BEEN SEEN FOR TWO YEARS. IT HAS NOT BEED DECIDED IF THE PATIENT WANTS THE DEVICE REPLACED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD TRIGGERED A LEAD WARNING FOR HIGH IMPEDANCE. AN ELECTROGRAM REVEALED INTERFERENCE AND OVERSENSING. THE LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE DEVICE HAD A SUDDEN CHANGE IN BATTERY VOLTAGE WITH RAPID BATTERY DEPLETION. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS FRACTURED. THE DEVICE AND LEAD WERE EXPLANTED AND NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PROTECTA XT VR	DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER	LWS	MEDTRONIC MED REL, INC.	D314VRG

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR		Hospitalization\| O\| R