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); Low impedance (2285); Ambient Noise Problem (2877)

Patient Problems Muscle Stimulation (1412); Fainting (1847); Pain (1994)

Event Date 01/16/2018

Event Type  Injury  

Manufacturer Narrative

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 patient was experiencing muscle stimulation and shooting pains into their abdomen.The patient also reported experiencing issues with fainting.Additional information provided from the field indicated there was oversensing of noise on the right ventricular (rv) channel that caused pacing inhibition with a period of asystole of up to six seconds.The patient was brought back in and surgical intervention was performed to reposition the system.Afterwards the patient was fine.The rv lead remains in service and there were no additional adverse patient effects reported.

Event Description

Boston scientific received information that this system was also exhibiting a decrease in shock impedance measurements.No further changes have been made and the system remains in service.No additional 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: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7296611
• MDR Text Key: 100938876
• Report Number: 2124215-2018-03274
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• PMA/PMN Number: P910073/S043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/15/2013
• 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: 03/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2011
• 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: D143
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention