Health Canada — Medical Devices · Canada · 2021-04-29 · Type II
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Reported risk: Medtronic has become aware of an issue that may cause unintended increased heating, specifically due to damage at the location where the cable enters the recharger antenna. Due to this damage causing unintended increased heating, patients have reported experiencing temporary discomfort (e.g. heating, burning, or shocking sensations) from the recharger or signs of heating on the skin, such as redness, blistering, or a burn resulting from prolonged exposure to heat.
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