MAUDE Adverse Event Report: CPI - DEL CARIBE EASYTRAK 2; IMPLANTABLE LEAD

Model Number 4543

Device Problem High impedance (1291)

Patient Problems Cardiopulmonary Arrest (1765); Ventricular Tachycardia (2132)

Event Date 04/25/2016

Event Type  Death  

Manufacturer Narrative

The device data was reviewed.The vt/vf was slow, just at or below the rate cut off of 190 bpm.Pacing was noted, due to the small signals below sensitivity.Undersensing was confirmed.A review of the lead measurements found normal values for the ra and rv leads; the lv lead exhibited intermittent high, out-of-range pacing impedance measurements.Episode v-1 started at 20:15 on (b)(6) 2016 and the last stored episode was v-27 started at 20:57 on (b)(6) 2016, indicating the patient was in the arrhythmia for approximately 40 minutes.Initial review of the episode and programming recommendations were provided to the physician.This report will be updated when additional information is received.

Event Description

Boston scientific received information that the patient implanted with this cardiac resynchronization therapy defibrillator (crt-d) was hospitalized for an unknown reason.While hospitalized, the patient developed a ventricular tachycardia (vt) for which they required 45 minutes of cardiopulmonary resuscitation and external defibrillation.Following the external shock the patient's rhythm converted to normal sinus rhythm.The patient was transferred to the intensive care unit (icu) and is currently intubated and on a ventilator.The physician alleged that the device malfunctioned and decreased sensing was observed.A history of high out-of-range left ventricular (lv) lead impedance measurements were noted in some of the device printouts provided.A copy of the device's memory was preserved and analyzed.Memory analysis confirmed ventricular fibrillation (vf) undersensing.

Manufacturer Narrative

Detailed review of this patient¿s device diagnostic data revealed that multiple episodes of vf were recorded (with slow vf occurring at or below the vt cut-off rate of 190 bpm).The device delivered a total of two successful 41 j shocks (during episodes v5 and v27).In four episodes (v1, v2, v11, and v16), the device could not reconfirm the episode and no shock was delivered.This was due to the patient¿s heart rate; the rate was just below the lowest ventricular cut-off rate of 190 bpm.There was some undersensing noted; this was the result of signals occurring below the programmed maximum sensitivity of 0.6 mv.Based on a detailed review of the device diagnostic data, engineers determined that the device-lead system functioned as designed/intended.

Event Description

The field representative later reported that this patient passed away.The physician had not determined the exact cause of death, or whether the vt/vf and/or the crt-d function caused or contributed to the patient's death.It was only confirmed that the patient died from heart failure.

• Brand Name: EASYTRAK 2
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer Contact: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5722923
• MDR Text Key: 47320980
• Report Number: 2124215-2016-08493
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/20/2015
• Device Model Number: 4543
• Other Device ID Number: EASYTRAK 2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/19/2016
• Initial Date FDA Received: 06/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: P053
• Patient Outcome(s): Death; Hospitalization; Life Threatening
• Patient Age: 58 YR