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

Model Number 0180

Device Problems Failure to Capture (1081); Over-Sensing (1438); Pacing Problem (1439); Pocket Stimulation (1463); Low impedance (2285); Ambient Noise Problem (2877); Capturing Problem (2891)

Patient Problem Muscle Stimulation (1412)

Event Date 04/20/2016

Event Type  malfunction  

Manufacturer Narrative

No further testing was performed to determine the root cause of the clinical observations.Device re-programming was performed on the rv channel and the patient will continue to be followed.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 exhibiting diaphragmatic stimulation on the right ventricular (rv) channel which was oversensed and resulted in pacing inhibition with 3 to 4 seconds of asystole.Additionally, there was some noise noted on the atrial channel.Impedance measurements were stable and within normal limits and the noise was not able to be re-created.No adverse patient effects were reported.

Manufacturer Narrative

Additional information was received stating that two months after the initial observations were reported, this patient was implanted with a left ventricular assisted device (lvad).Post operative threshold measurements were 2.0v to 2.5v and impedance was 1200 ohms on the rv channel.However, a few days later, rv pacing impedance had decreased to 600 ohms and there was no capture.A post operative chest x-ray was unremarkable for any movement of the rv lead.A revision procedure was performed and the rv lead and device were removed from service and replaced.No performance issues were noted with the left ventricular (lv) lead.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.

Manufacturer Narrative

Additional details were received that there was no lead damage revealed via fluoroscopy or visually at the explant procedure.There also was no damage to the device header noted at the explant procedure.The product has been returned and is being evaluated in our post market quality assurance laboratory.This product issue will be updated when evaluation is complete.

Manufacturer Narrative

Upon receipt in our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Visual inspection was unremarkable for any anomalies.Resistance and pressure testing was performed which confirmed the electrical continuity and insulation integrity of the lead.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

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• 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: 5789490
• MDR Text Key: 49385532
• Report Number: 2124215-2016-09616
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup,Followup
• Report Date: 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/17/2017
• Device Model Number: 0180
• Other Device ID Number: ENDOTAK RELIANCE SG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/05/2016
• Initial Date FDA Received: 07/13/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 08/02/2016; 08/02/2016; 10/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2015
• 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: H135
• Patient Age: 71 YR