Optim Coated Leads with Internal Abrasion requiring patient intervention
Here are two of internal abrasion causing noise. Just replace the Maude ID number in the links about the externalized conductors and you can read it on the FDAs website. Internal abrasion is a new term I think. Maybe the optim keeps the cables in the device but the silicone still wears away on the inside causing the etfe coated wires to rub against each other resulting in noise or electrical shorts between the cables.
Maude ID 2738388.
ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION RIATA ST OPTIM PASSIVE FIXATION LEAD DEFIBRILLATION LEAD
Model Number 7070/65
Event Date 07/25/2012
Event Type Injury Patient Outcome Required Intervention
All information provided by manufacturer, no medwatch form was received a partial lead was returned. Internal abrasion was noted at 6 cm to 7. 2 cm from the distal tip and etfe damage on the rv ca bles at the proximal edge of the rv shock coil was observed. Internal abrasion was observed at 14. 3 cm to 15. 5 cm from the distal tip, the overlying optim sheath was not damaged. An internal abrasion under the svc shock coil was observed at 7. 9 cm from d distal tip with etfe cable intact. No anomaly was noted that could cause the reported noise or low impedance.
It was reported that an asymptomatic patient presented to the clinic after receiving patient notifier. Low pacing lead impedance and oversensing were observed. The noise was reproduced with arm movement. Externalized conductors were observed via fluoro prior to explant. The lead was explanted replaced.
Maude ID 2720759
ST JUDE MEDICAL RIATA ST OPTIM ACTIVE FIXATION LEAD NONE
Model Number 7020/60
Event Date 07/29/2012
Event Type Injury Patient Outcome Life Threatening
Pt received sub-therapeutic shocks from her icd lead, resulting in persistent ventricular arrhythmias potentially life threatening. The lead was extracted and returned to st jude medical for analysis. Lead was determined to have an internal insulation fracture.