Medtronic has logged 15 complaints concerning the selection of an incompatible component based on the intended system configuration between 1 January 2020 and 12 August 2026. The issues involved the use of an incompatible lead or percutaneous extension, which resulted in delayed surgeries or the need for surgical replacement of the component.
A review of the complaint data confirmed that the product is functioning as designed and identified no device or product performance problems.
규제 업데이트2026년 9월 24일•1분 읽기
Medtronic Reports 15 Complaints Over Incompatible Component Selection
Medtronic logged 15 complaints from Jan 2020 to Aug 2026 involving incompatible leads or extensions, causing surgery delays or replacements, but found no device performance issues.
PharmaCountry 팀이 정리했습니다 · 출처: Health Canada
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