It was reported that the patient went into cardiac arrest and had a long bout of cardiopulmonary resuscitation, however, the patient passed.The patient¿s spouse heard the device tone and thought that the patient may have received a shock however, no shock was delivered.It was further noted that on the date prior to the patient passing, the stored ventricular tachycardia non-sustained (vt-ns) and high rate non-sustained (hr-ns) electrograms (egm) appeared to be potential agonal type rhythm and the right ventricular (rv) lead triggered a lead integrity alert (lia).It was also reported that there was oversensing and undersensing at times during vt-ns and hr-ns episodes with no capture on the right atrial (ra) lead and rv lead on stored and current egms.Lastly, it was noted that there was possible high thresholds on the left ventricular (lv) lead.
|
Continuation of d10: 5076-45, lead, implanted (b)(6) 2017.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
|