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

Model Number 1175

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2015

Event Type  malfunction  

Event Description

Boston scientific received information that during a routine device replacement procedure, an unspecified lead was unable to be removed from the device.The set screw appeared to have been stripped.The physician used a bone cutter tool to cut the back edge off the header.The lead pin was successfully removed from the device header.No adverse patient effects were reported as a result.The device was to be returned for analysis.

Event Description

Additional information was received that this device was returned for reliability analysis.

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.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, the device header was examined.Visual inspection noted that the device header was detached.With manipulation, the device was then exposed to simulated heart load conditions, and the pacing and sensing functions were tested.The device operated appropriately, according to its performance specifications with no interruptions in therapy output or programmer communication at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.

• Brand Name: DISCOVERY
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): GUIDANT CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer (Section G): GUIDANT CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer Contact: sonali vasekar ; 4100 hamline ave. n; st. paul, MN 55112 ; 6515824786
• MDR Report Key: 4656939
• MDR Text Key: 5727775
• Report Number: 2124215-2015-04185
• Device Sequence Number: 1
• Product Code: DXY
• 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: 04/06/2015

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: 06/01/2002
• Device Model Number: 1175
• Other Device ID Number: DISCOVERY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/06/2015
• Initial Date FDA Received: 04/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2001
• 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: 0465; S204; 1175
• Patient Age: 58 YR