MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND CONTAK RENEWAL TR; IMPLANTABLE CHF GENERATOR

Model Number H125

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2014

Event Type  malfunction  

Event Description

Boston scientific received information that this cardiac resynchronization therapy pacemaker (crt-p) is near elective replacement indicator (eri).A boston scientific company representative verified that the magnet rate is still at 100 bpm.Additional information indicates that the crt-p was checked recently, however the nurse at the clinic could not recall any contributing factors to early battery depletion.The crt-p remains in service.No adverse patient effects reported.

Event Description

Additional information was received indicating that the device was explanted three months later due to normal battery depletion (nbd).No adverse patient effects were reported.

Event Description

Boston scientific technical services (ts) confirmed the magnet rate of 100 paces per minute was normal device function and does not indicate premature battery depletion (pbd).

Manufacturer Narrative

(b)(4).As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).At this time, the product has not been returned.Attempts to obtain the device for analysis were unsuccessful.If the device is returned, analysis will be performed and this event will be updated.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

• Brand Name: CONTAK RENEWAL TR
• Type of Device: IMPLANTABLE CHF 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN 55112 ; 6515824786
• MDR Report Key: 4166906
• MDR Text Key: 4872599
• Report Number: 2124215-2014-18060
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2011
• Device Model Number: H125
• Other Device ID Number: CONTAK RENEWAL TR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/19/2014
• Initial Date FDA Received: 10/13/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/10/2015; 04/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2009
• 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: 4088; 4086; 4518; H125
• Patient Age: 87 YR