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U.S. Department of Health and Human Services

Class 2 Device Recall DBS Extension Kit for Deep Brain Stimulation

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 Class 2 Recall
DBS Extension Kit for Deep Brain Stimulation
see related information
Date Posted December 19, 2012
Recall Status1 Terminated on November 14, 2013
Recall Number Z-0567-2013
Recall Event ID 63777
Premarket Approval
PMA Numbers
P960009/S007 P960009/S051 P960009/S134
Product Classification Stimulator, Electrical, Implanted, For Parkinsonian Tremor - Product Code MHY
Product Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in: Medtronic, Inc. Villalba, Puerto Rico. Medtronic® DBSTM Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Parkinson's Disease is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. STN/GPi target system components: ® Kinetra® Model 7428 or Soletra® Model 7426 Neurostimulator ® Activa® PC Model 37601, Activa RC Model 37612, Activa SC Model 37602, or Activa SC Model 37603 Neurostimulator ® Model 7482, Model 7482A, Model 7483, Model 37085, or Model 37086 Extension ® Model 3387 or Model 3389 Lead Medtronic DBS Therapy for Tremor - Unilateral thalamic stimulation of the ventral intermediate nucleus (VIM) using Medtronic DBS Therapy for Tremor is indicated for the suppression of tremor in the upper extremity. The system is intended for patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability. VIM target system components: ® Soletra Model 7426 Neurostimulator ® Activa PC Model 37601, Activa RC Model 37612, Activa SC Model 37602, or Activa SC Model 37603 Neurostimulator ® Model 7482, Model 7482A, Model 7483, Model 37085, or Model 37086 Extension ® Model 3387 or Model 3389 Lead.
Code Information NHU236350V to NHU236373V; NKN037257V to NKN037259V; NKN037372V to NKN037387V; NKN037476V to NKN037507V; NKN037692V to NKN037698V; NKN037772V to NKN037779V; NKN037790V to NKN037810V; NKN037812V to NKN037840V.
Recalling Firm/
Manufacturer
Medtronic Neuromodulation
7000 Central Ave NE
Minneapolis, Minnesota 55432-3568
Manufacturer Reason
for Recall
Medtronic has identified 140 Restore DBS Extension Kits (model numbers 7482, 37085, and 37086), which may contain a damaged winged connector boot. The connector boot may not have been molded properly and may be cracked. Approximately 14% of the 140 affected extension kits may contain a damaged radiopaque winged connector boot.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Medtronic beginning November 15, 2012 , initiated a retrieval of unused inventory in the field. In the US, three customers were identified. Medtronic field representatives visited these US accounts to facilitate product identification and removal. If product was removed a letter was provided to the facility describing the recall. The letter dated November 2012, "Medtronic Medical Device recall" was addressed to the Hospital. Beginning on December 3, 2012, Medtronic mailed healthcare professional letters to physician who have used the affected product. The Medtronic " Medical Device Recall" letter was dated November 2012. The letter identified the problem, the product involved in the recall, and provided advise if the product was used. A reply card was provided to each physician to confirm they have received and understood the communication. For further questions please call (763) 514-2000.
Quantity in Commerce 140 units
Distribution Worldwide Distribution -- USA (nationwide) including the states of CT, MI, NH, NY, OH, PA and VT., and the countries of AUSTRALIA, JAPAN, BELGIUM, FRANCE, GERMANY, ITALY, NETHERLANDS, POLAND, SPAIN, SWITZERLAND, TURKEY and UNITED KINGDOM.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MHY and Applicant = MEDTRONIC VASCULAR
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