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

Model Number 0185

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

Patient Problem Muscle Stimulation (1412)

Event Date 04/05/2016

Event Type  malfunction  

Manufacturer Narrative

No further information concerning this report is available at this time.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that the right ventricular (rv) lead exhibited oversensing of noise leading to pacing inhibition.No asystole was noted the noise was able to be reproduced with isometrics and was determined to be muscle stimulus.The noise was detected on previous interrogation approximately three months earlier and was being monitored.During a device change out procedure, the rv lead was surgically abandoned.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: 6019235
• MDR Text Key: 57059050
• Report Number: 2124215-2016-12067
• 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: Physician
• Type of Report: Initial
• Report Date: 07/05/2016

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: 03/09/2011
• Device Model Number: 0185
• Other Device ID Number: ENDOTAK RELIANCE G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/05/2016
• Initial Date FDA Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2009
• 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: 0185; 4136; 4543; N119
• Patient Age: 86 YR