TENDRIL STS (Abbott Medical (CRM-Sylmar)) — Malfunction
A malfunction was reported involving the TENDRIL STS device manufactured by Abbott Medical (CRM-Sylmar). The source characterizes the event as a device malfunction without providing specific details regarding the nature of the failure.
This affects Abbott Medical, healthcare providers utilizing cardiac rhythm management systems, and regulatory or quality personnel responsible for monitoring implantable lead performance.
While the source provides limited detail regarding the specific failure mode, a malfunction in an implantable cardiac lead typically necessitates close monitoring of post-market performance data. This event may trigger internal quality investigations or updated risk assessments for the product line. Regulatory teams should consider this report in the context of broader trend analysis for cardiac rhythm management devices to identify potential systemic issues.
Review post-market surveillance data for the TENDRIL STS lead to determine if internal reporting thresholds for malfunctions have been met. Quality teams should ensure that any similar performance issues are captured within the existing CAPA framework. Clinical teams may need to monitor device performance data for trends related to lead integrity or electrical malfunction.
Event type: Malfunction. Device: TENDRIL STS by Abbott Medical (CRM-Sylmar).
Open in openFDA / FDA.gov