MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND PUNCTUA; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number P052

Device Problems High impedance (1291); Pocket Stimulation (1463); Failure to Sense (1559); Ambient Noise Problem (2877)

Patient Problems Muscle Stimulation (1412); No Consequences Or Impact To Patient (2199)

Event Date 05/01/2016

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 left ventricular (lv) lead and cardiac resynchronization therapy pacemaker (crt-p) exhibited high pacing thresholds and high out-of-range pace impedance measurements.At the time of revision ventricular output was set to right ventricle only with the last recorded lv threshold at maximum device output; it remains unknown if the lead exhibited loss of capture (loc) at the time of the measurement.Daily lv impedance measurements had also been turned off after approximately one year of implant due to phrenic nerve stimulation; variable sensing of lv activity was also noted.During preparations for surgical revision, noise was also observed on the lv channel upon manipulation.A tug test was performed confirming adequate lead connection to the device.When the lv lead was connected to a pacing system analyzer (psa) bipolar sensing could not be achieved and pacing output at 5v was ineffective.There were no signs of physical damage to the lead when examined during the procedure as well as via x-ray.The lead was surgically abandoned and replaced.No adverse patient effects were reported.

• Brand Name: PUNCTUA
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 6022011
• MDR Text Key: 57145963
• Report Number: 2124215-2016-13588
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/07/2013
• Device Model Number: P052
• Other Device ID Number: PUNCTUA CRT-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2011
• 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: 4543; P052
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 84 YR