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Class 2 Device Recall Evera ICD |
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Date Initiated by Firm |
August 12, 2016 |
Date Posted |
August 25, 2016 |
Recall Status1 |
Terminated 3 on January 20, 2017 |
Recall Number |
Z-2651-2016 |
Recall Event ID |
74923 |
PMA Number |
P980016S382 |
Product Classification |
Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
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Product |
Medtronic, Evera Implantable Cardioverter Defibrillators:
Product Model EVERA XT DDBB1D1, DDBB1D4, DDBB2D1, DDBB2D4, DVBB2D4, DVBB1D1. EVERA S DDBC3D1, DDBC3D4
Product Usage: The Medtronic Evera DR dual chamber and Evera VR single chamber, implantable cardioverter defibrillator (lCD) are a family of multiprogrammable cardiac devices that monitor and regulate the patients heart rate by providing dual or single chamber rate-responsive bradycardia pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies (dual-chamber devices only).
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Code Information |
Product Name: Evera XT DR lCD. Models: DDBB1D4, DDBB1D1, DDBB2D4, DDBB2D1. Serial Numbers: BWC202738H, BWC202754H, BWB202998H, BWB203157H, BWB203167H, BWB203173H, BWB203186H, BWE601558S, BWE601571S, BWE601578S, BWE601579S, BWE601581S, BWE601589S, BWE601591S, BWE601594S, BWE601600S, BWE601605S, BWD602122S. Product Name: Evera S DR lCD. Models: DDBC3D1, DDBC3D4. Serial Numbers: BWG600597S, BWF600969S, BWF600970S, BWF600972S, BWF600973S, BWF600975S, BWF600977S, BWF600978S, BWF600979S, BWF600983S, BWF600984S, BWF600985S, BWF600987S, BWF600989S, BWF600991S, BWF600992S, BWF600996S, BWF601001S. Product Name: Evera XT VR lCD. Models: DVBB1D1, DVBB2D4. Serial Numbers: BWI201423H, BWI201436H, BW1201440H, BWI201451H, BWI201454H, BWI201462H, BWI201473H, BWJ601102S, BWJ601108S, BWJ601112S, BWJ601479S, BWJ601101S, BWJ601103S, BWJ601106S. |
Recalling Firm/ Manufacturer |
Medtronic Inc., Cardiac Rhythm and Heart Failure 8200 Coral Sea St NE Mounds View MN 55112-4391
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For Additional Information Contact |
Medtronic Technical Services 800-723-4636
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Manufacturer Reason for Recall |
78 Viva CRT -Ds and Evera ICDs that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a low resistance path developing within the circuit component. There have been seven (7) confirmed failures (9%) through July 16, 2016. Reported complications have included shortness of breath, pocket heating, low heart rate, and early device explant.
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Consignees were sent or hand delivered on August 12, 2016 a Medtronic "Urgent Medical Device Correction" letter dated August 2016. The letter was addressed to Physician. The letter described the problem and the devices involved in the recall. The letter described a number of "Patient Management Recommendations". For questions contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636. |
Quantity in Commerce |
78 (39 US, 39 OUS) |
Distribution |
Worldwide Distribution - US Nationwide in the states of US: AZ, CA, FL, GA, IL, KY, MD, MN, NJ, NY, NC, OH, OK, PA, PR, TX. and countries of: Australia, Finland, France, Germany, Iran, Italy, Japan, Korea, Netherlands, Puerto Rico, Saudi Arabia, Spain, and United Kingdom. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database |
PMAs with Product Code = LWS and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PMAs with Product Code = LWS and Original Applicant = Medtronic, Inc.
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