MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND INGENIO; IMPLANTABLE PULSE GENERATOR

Model Number K063

Device Problems Over-Sensing (1438); Ambient Noise Problem (2877)

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

Event Date 08/24/2018

Event Type  malfunction  

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 during an interrogation another manufacturer's right atrial (ra) lead had triggered the lead safety switch (lss) due to high out of range pacing impedance measurements of greater than 2000 ohms.Farfield oversensing was also observed and thought to be due to the pacemaker sensing the minute ventilation signal.The minute ventilation feature was programmed off.Boston scientific technical services (ts) discussed that the high impedance measurements contribute to the sensing of the minute ventilation.An x-ray was taken which did not reveal any significant findings.Thus a revision procedure was performed.During the procedure the other manufacturer's ra lead was tested on a pacing system analyzer (psa) and yielded the same high out of range impedances.A fracture was suspected.Subsequently the ra lead was surgically abandoned and successfully replaced.The pacemaker remained in service and no additional adverse patient effects were reported.

• Brand Name: INGENIO
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer (Section G): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 8071473
• MDR Text Key: 127219338
• Report Number: 2124215-2018-19131
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• PMA/PMN Number: N970003/S132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/17/2015
• Device Model Number: K063
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2013
• 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: 79 YR