FDA Adverse Event Injury Summary report: N

SPRINT QUATTRO SECURE

MDR report key: 1991828 · Received February 15, 2011

Report

Report Number: 2649622-2011-02569
Event Type: Injury
Date Received: February 15, 2011
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: LWS
PMA / PMN Number: P920015/S24
Removal / Correction Number: ASKU
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

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.

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 REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS OVERSENSING THE T-WAVE WHILE THE PATIENT WAS EXERCISING AND THE PATIENT RECEIVED INAPPROPRIATE THERAPY. IT WAS LATER REPORTED THAT THE T-WAVE OVERSENSING WAS OBSERVED WHEN THE PATIENT WAS HAVING PREMATURE VENTRICULAR CONTRACTIONS. THE LEAD IS STILL-IN-USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS OVERSENSING THE T-WAVE WHILE THE PATIENT WAS EXERCISING AND THE PATIENT RECEIVED INAPPROPRIATE THERAPY. THE LEAD IS STILL-IN-USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SPRINT QUATTRO SECURE	IMPLANTABLE TACHY LEAD	LWS	MEDTRONIC PUERTO RICO, INC.	6947	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR		Life Threatening\| O	7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB\| 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB