FDA Adverse Event Injury Summary report: N

2124215-2016-00634

MDR report key: 5373258 · Received January 17, 2016

Report

Report Number: 2124215-2016-00634
Event Type: Injury
Date Received: January 17, 2016
Date of Event: October 30, 2015
Report Date: December 3, 2015
Manufacturer: GUIDANT PUERTO RICO BV
Product Code: NIK
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE ARTICLE AUTHOR(S) WERE UNSUCCESSFUL. THE FINDINGS OF THE STUDY WERE SUMMARIZED IN THE ARTICLE: YAMASHITA, S., K. FUKUZAWA, ET AL. (2015). "THE EFFECTIVENESS OF CARDIAC RESYNCHRONIZATION THERAPY FOR PATIENTS WITH NEW YORK HEART ASSOCIATION CLASS IV NON-AMBULATORY HEART FAILURE." JOURNAL OF ARRHYTHMIA 31(4): 221-225.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM A STUDY DESIGNED TO EVALUATE THE EFFECTIVENESS OF CARDIAC RESYNCHRONIZATION THERAPY FOR PATIENTS WITH NEW YORK HEART ASSOCIATION CLASS IV, NON-AMBULATORY HEART FAILURE. THE RETROSPECTIVE DATABASE STUDY INVOLVED A TOTAL OF 29 PATIENTS IMPLANTED WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BETWEEN 2003 AND 2011. BSC CRT DEVICES (MODELS UNKNOWN), ALONG WITH TWO OTHER MANUFACTURES, WERE SELECTED FOR IMPLANT. OF THE PATIENT'S IMPLANTED, TWO DEVICE RELATED INFECTIONS WERE REPORTED. THE FIRST AT 344 DAYS POST-IMPLANT AND THE SECOND, 224 DAYS POST-IMPLANT. THE FIRST PATIENT WAS SUBJECTED TO PRODUCT REMOVAL AND ROUTINE INFECTION CARE AND ANOTHER DEVICE LATER IMPLANTED. THE SECOND PATIENT, ALSO HAD THEIR DEVICE REMOVED BUT ELECTED TO FORGO FURTHER CRT-D THERAPY DUE TO NON-RESPONSIVE BI-VENTRICULAR PACING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED AS PART OF THIS DATA REVIEW.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
31349			NIK	GUIDANT PUERTO RICO BV	TACHY DEVICE

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| L\| R