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

Model Number 4542

Device Problems Fracture (1260); High impedance (1291)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Ventricular Fibrillation (2130); Heart Failure (2206); No Known Impact Or Consequence To Patient (2692)

Event Date 12/15/2016

Event Type  Death  

Manufacturer Narrative

A revision procedure was performed over a week later where the rv lead was surgically abandoned and the crt-d was explanted.The cause of the high shocking impedance remained unknown.It was noted that at the revision procedure the lv lead impedance measurements were within range and all other measurements were good.Since the lead appeared in a good position, they physician opted to leave the lv lead implanted and programmed to unipolar in hopes of resolving the issue.No additional adverse patient effects were reported.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that the right ventricular (rv) lead exhibited high shock impedance of 115 ohms.Review of the measurements found that the impedance measurement had been trending high for some time.Boston scientific technical services (ts) was consulted and discussed troubleshooting options.It was noted that the patient had already left the clinic.Over eight months later the patient became non-responsive and paramedics were called.Cardiopulmonary resuscitation (cpr) was performed and the patient was revived after five minutes.A remote interrogation was performed which showed the patient had ventricular fibrillation (vf) and seven shocks were administered.The patient's vf was successfully converted on the seventh shock.Further review found high out of range left ventricular (lv) pacing impedance measurements of greater than 2500 ohms along with high out of range shock impedance measurements of greater than 125 ohms for the right ventricular (rv) lead.It was noted that the lv impedance measurements had been intermittently high for the last month.An in office interrogation showed shock impedance measurements around 110 ohms.The patient was admitted for heart failure.The physician believed that the patient's increased heart failure was due to a lv lead fracture, however this has not been confirmed.The physician also noted that he believed the ineffectiveness of the first 6 shocks was due to the patient¿s decompensation, not the high shock impedance on the rv lead.

Event Description

Boston scientific received additional information that the patient died approximately three months after the revision procedure.An online obituary stated that the patient died peacefully at her residence, surrounded by family.The obituary also noted that contributions could be made at a local hospice facility.The cause of death was not provided.According to remote monitoring data, the patient was bi-ventricular paced 96 percent of the time since the last reset, which was (b)(6) 2016.The field representative was also contacted and noted that although the patient was being paced, capture could not be confirmed with the lv lead.Since the clinic was not aware of the patient's death, there was no further information the field representative could provide.On (b)(6) 2017 (8 days before the lv lead was reprogrammed) a remote monitoring transmission was performed.From this transmission, electrograms were available to review.The investigation is ongoing pending review by boston scientific's medical safety committee.

• 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: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 6476151
• MDR Text Key: 72251119
• Report Number: 2124215-2017-02034
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/20/2006
• Device Model Number: 4542
• 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
• Date Manufacturer Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2004
• 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: 4470; 4542; H170; N119
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 79 YR