MAUDE Adverse Event Report: CPI - DEL CARIBE ENDOTAK RELIANCE

Model Number 0292

Device Problems High impedance (1291); Device Contamination With Biological Material (2908)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/10/2017

Event Type  malfunction  

Manufacturer Narrative

Attempts were made to obtain additional information; however, no information was available.At this time, the lead remains in service.If additional information is received, this report will be updated.

Event Description

Boston scientific received information that this right ventricular (rv) defibrillation lead exhibited shock impedance measurements of greater than 125 ohms.There was no noise noted, and there were no changes to the threshold or sensing measurements.Troubleshooting and programming options were discussed.No adverse patient effects were reported.The lead remains in service.

Manufacturer Narrative

At this time, the lead remains in service.If additional information is received, this report will be updated.

Event Description

Additional information was received which noted that the patient would continue to be monitored.During the patient's next scheduled follow-up visit, the physician planned to increase the shock impedance alert range.No adverse patient effects were reported.The lead remains in service.

Event Description

Additional information was provided which noted that the patient was brought to their clinic for additional troubleshooting.Overdrive pacing was performed, which produced shock impedance measurements of 141 to 151 ohms.The physician believed there was a calcium/substrate build-up on the rv defibrillation coil.The patient was referred to discuss a lead replacement with their physician.No additional adverse patient effects were reported.The lead remains in service.

Event Description

Additional information was provided which noted that commanded shocks were performed due to the high shock impedance measurements.This revealed normal shock impedance measurements.No additional adverse patient effects were reported.The lead remains in service.

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

Additional information was received which noted that this lead was abandoned to implant the patient with an s-implantable cardioverter defibrillator (icd) system.No additional adverse patient effects were reported.

• 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: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7190219
• MDR Text Key: 97855184
• Report Number: 2124215-2017-20180
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• PMA/PMN Number: P910073/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2014
• Device Model Number: 0292
• 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: 07/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2012
• 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: 174 MO