FDA Adverse Event Injury Summary report: N

SPRINT QUATTRO SECURE

MDR report key: 3862383 · Received June 10, 2014

Report

Report Number: 2649622-2014-06941
Event Type: Injury
Date Received: June 10, 2014
Date of Event: March 5, 2014
Report Date: March 13, 2014
Manufacturer: MPRI
Product Code: LWS
PMA / PMN Number: P920015
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: PHYSICIAN

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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE EXPOSED SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL BECAME EXTRINSICALLY FRACTURED DUE TO A CUT. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. THE LEAD WAS RETURNED WITH AN EXTRINSIC FRACTURE/CUT ON THE SVC EXPOSED COIL. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) HAD BEEN TRIGGERED DUE TO A HIGH NUMBER OF SHORT INTERVAL COUNTS (SIC) AS WELL AS NON-SUSTAINED TACHYCARDIA (NST) EPISODES RESULTING FROM OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. THE EPISODES COULD NOT BE DUPLICATED WITH PROVOCATIVE TESTING. THE PHYSICIAN DECIDED TO OPEN THE POCKET IN ORDER TO ASSESS THE LEAD AT WHICH TIME A BREAK IN THE PROXIMAL PORTION OF THE LEAD WAS DISCOVERED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
337831	SPRINT QUATTRO SECURE	DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER	LWS	MPRI	694758

Patients

Seq	Age	Sex	Outcome	Treatment
1	00048 YR		Hospitalization\| R	D314VRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR