MAUDE Adverse Event Report: CPI - DEL CARIBE ENDOTAK RELIANCE; IMPLANTABLE LEAD

Model Number 0185

Device Problems Failure to Capture (1081); Over-Sensing (1438); Pacing Problem (1439); Pocket Stimulation (1463); Ambient Noise Problem (2877)

Patient Problems Ventricular Tachycardia (2132); Complaint, Ill-Defined (2331)

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

A boston scientific technical services consultant discussed that lv pacing cannot be ensured since it is based on rv timing and there could be loss of bi-ventricular pacing.Isometrics produced some muscle noise and loss of capture.The noise was mainly due to the use of the patient¿s exercise training band.The physician advised the patient to not continue the exercises.Due to the patient¿s fragile condition, the physician will continue to monitor the patient.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 this system was experiencing noise on both channels of the right ventricular (rv) lead.The noise on the pace/sense channel was oversensed resulting in pacing inhibition for 3-4 seconds at which time the patient was symptomatic.There were anti-tachycardia pacing (atp) events that appear to be appropriate.Atrial noise was also noted with atrial tachycardia response (atr) events.The patient has an left ventricular assist device (lvad) and the caller was inquiring if this device could be causing the noise and if there would be lv pacing if there was noise on the rv.No adverse patient effects were reported.

• Brand Name: ENDOTAK RELIANCE
• 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: 5601733
• MDR Text Key: 43451710
• Report Number: 2124215-2016-05489
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910073/S043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/11/2007
• Device Model Number: 0185
• Other Device ID Number: ENDOTAK RELIANCE G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2005
• 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
• Patient Age: 82 YR