MAUDE Adverse Event Report: CPI - DEL CARIBE ENDOTAK RELIANCE

Model Number 0292

Device Problems Pocket Stimulation (1463); Low impedance (2285)

Patient Problem Muscle Stimulation (1412)

Event Date 04/01/2018

Event Type  malfunction  

Manufacturer Narrative

The lead remains in service at this time.If additional information is received, this report will be updated.

Event Description

Boston scientific received information that this right ventricular (rv) defibrillation lead exhibited one shock impedance measurement of 0 ohms.The shock impedance trend showed stable measurements between 60 and 85 ohms.Boston scientific technical services (ts) discussed electromagnetic interference (emi) as a likely cause of the low shock impedance measurement; however, the patient could not recall what they were doing at that time.The patient also had phrenic nerve stimulation approximately one time per month.This was unable to be recreated while the patient was in the clinic; however the outputs were decreased which resolved the issue.No adverse patient effects were reported.The lead remains in service.

• Brand Name: ENDOTAK RELIANCE
• 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 ; 6515826168
• MDR Report Key: 7984060
• MDR Text Key: 124363222
• Report Number: 2124215-2018-18442
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• PMA/PMN Number: P910073/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/20/2016
• Device Model Number: 0292
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2014
• 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: 0292; 4674; G148; MISMATCH
• Patient Age: 73 YR