MAUDE Adverse Event Report: CPI - DEL CARIBE ENDOTAK RELIANCE

Model Number 0293

Device Problems Over-Sensing (1438); Pocket Stimulation (1463); Low impedance (2285); Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2015

Event Type  Injury  

Event Description

Additional information was received that further testing was performed at a later date; however, the noise could not be reproduced.No x-rays were taken and no further testing was performed.No adverse patient effects were reported.The physician has decided to continue monitoring the patient using the remote monitoring system.

Manufacturer Narrative

(b)(4).The icd and rv lead remain implanted and in service.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

At a later date, it was reported that a revision procedure was performed.Prior to the revision, testing of the icd and rv lead revealed that the pacing impedance measurements fluctuated when the patient moved their left arm.In addition, the patient experienced pocket stimulation when pacing threshold measurements were performed.During the revision, the physician was unable to retract the helix of the rv lead.As a result, the rv lead was capped and successfully replaced.Measurements on the newly implanted rv lead were all in normal range.The icd remains implanted and in service.No additional adverse patient effects were reported.

Manufacturer Narrative

(b)(4).As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Manufacturer Narrative

(b)(4).Once any additional information is available, this report will be updated.

Event Description

Boston scientific received information that during a normal follow up, this right ventricular (rv) lead and implantable cardioverter defibrillator (icd) presented with low pacing impedance measurements.Several of the measurements were below 200 ohms.In addition, there was an episode recorded in the arrhythmia logbook due to noise being oversensed on both the rv and shock channels.No adverse patient effects were reported.A memory download was performed and sent to boston scientific technical services (ts) for further review.A ts consultant reviewed the data and confirmed that the pacing impedance measurements had been decreasing over time.Additional troubleshooting was also provided to help determine the reason for the observations.At this time, the icd and rv lead remain implanted and 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN 55112 ; 6515824786
• MDR Report Key: 4652477
• MDR Text Key: 5626297
• Report Number: 2124215-2015-01219
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• 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,Followup
• Report Date: 02/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/06/2013
• Device Model Number: 0293
• Other Device ID Number: RELIANCE 4-SITE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2011
• 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: A155; F052; 0293; 4096; 0185
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 69 YR