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

Model Number T180

Device Problems Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Failure to Sense (1559); Device Sensing Problem (2917); Material Integrity Problem (2978)

Patient Problems Cardiac Arrest (1762); Fall (1848); Hematoma (1884); Complaint, Ill-Defined (2331)

Event Date 06/22/2014

Event Type  Injury  

Event Description

Boston scientific received information that this patient had sustained a fall and went to the emergency room.A review of the arrhythmia logbook (al) did not identify any arrhythmia's associated with the fall.Device interrogation revealed a rhythm in the 40's, and noise which was oversensed resulting in pacing inhibition and asystole greater than two seconds.Additionally, there was no capture or sensing.A review of the daily measurements noted normal impedances until this day when the impedance had increased.A revision procedure was performed and a large hematoma was observed over the pocket and there was bleeding in the pocket.Visual inspection of the device revealed the header was completely detached.The leads were removed from the device and testing confirmed no lead issues.The patient is elderly and does not need ambulatory therapy.The physician has no plans to implant another implantable cardioverter defibrillator (icd) and a pacemaker was implanted without further incident.No adverse patient effects were reported.

Event Description

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Manufacturer Narrative

(b)(4).The device is being evaluated in our post market quality assurance laboratory.This product issue will be updated when evaluation is complete.

Manufacturer Narrative

(b)(4).Upon receipt in our post market quality assurance laboratory, visual inspection confirmed the clinical observation of a separated header.Laboratory analysis concluded that this header damage likely caused or contributed to the clinical observations.Manufacturing enhancements have been implemented to make the header bond more robust.No other adverse events have been reported.This product issue will be udpated if additonal information is received.

• Brand Name: VITALITY
• 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 55112 ; 6515824786
• MDR Report Key: 3939359
• MDR Text Key: 4578702
• Report Number: 2124215-2014-14025
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 07/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/26/2008
• Device Model Number: T180
• Other Device ID Number: VITALITY DR HE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/17/2014
• Initial Date FDA Received: 07/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2007
• 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; MISMATCH; 438-10; 1831; T180; 5024M; 294-23E; 0134; 4136
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 93 YR