Device Recall VITALITY DR ICD 의 리콜

Recall

46297

Class 2

Z-1513-2008

2008-01-07

2008-08-21

Terminated

United States

2008-12-30

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67155

Repetitive mechanical stress applied to the titanium case can induce component damage and device malfunction in certain icd and crt-d devices implanted subpectorally with the serial number facing the ribs. devices implanted subcutaneously or in a subpectoral position with the serial number facing away from the ribs are not included in this advisory. this update identifies additional vitality icd.

An Urgent Medical Device Information Update to May 2006 Product Advisory, dated January 04, 2008, was sent to implanting physicians and physicians following implanted devices beginning Monday, January 07, 2008. The letter described a malfunction that can occur when the ICD is implanted subpectorally with the serial number facing the ribs. Devices implanted subcutaneously or in a subpectoral position with the serial number facing away from the ribs are not included in this advisory. The physicians were asked to review records to determine if an affected device was implanted subpectorally. An AP radiograph should be done to determine specific device orientation for subpectoral implants. If a subpectoral implant is in a susceptible orientation, consider repositioning or replacement for physically active patients who regularly need device therapy. Follow patients with susceptible devices at 3-month intervals.