FDA-Device2013-03-27Class II
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
Boston Scientific CRM Corp
Hazard
An internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. Should this occur, the defibrillator would not be able to deliver therapy or communicate with the Q-TECH Model 2020 programmer, and would be unable to emit tones or otherwise respond to magnet application.
Sold states
Worldwide Distribution, USA including the states of AZ, CA, CO, DC, GA, IL, MD, MA, MN, NJ, NY, NC, OH, PA, SC, VA, WA and the countries of AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, IRELAND, ITALY, NETHERLANDS, NEW ZEALAND, PORTUGAL, SLOVAKIA, SPAIN, SWEDEN, SWITZERLAND, and the UNITED KINGDOM.
Affected count
2090 (570 USA; 1520 OUS)
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Products
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0965-2013Don't want to check this manually?
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