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

Model Number 1175

Device Problems Connection Problem (2900); Material Integrity Problem (2978)

Patient Problem Dizziness (2194)

Event Date 01/09/2015

Event Type  Injury  

Manufacturer Narrative

The device is being evaluated in our post market quality assurance laboratory.This product issue will be updated when analysis is complete.

Event Description

Boston scientific received information that this patient stated he had not been feeling well and was experiencing lightheadedness and his heart rate was 60 to 65 beats per minute.In addition, the physician stated that the patient needed a device change out.A boston scientific technical services consultant advised the patient to contact the clinic about the experienced symptoms.The device was explanted four months after this patient's call.Physical damage to the device header was observed.Additionally, the lead was stuck in the device and setscrew issues were experienced.No adverse patient effects were reported.

Manufacturer Narrative

Upon receipt in our post market quality assurance laboratory, a thorough evaluation of the device was performed.Visual inspection noted medical adhesive in the lead barrel which could cause the lead to become stuck.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output 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 ; 6515824786
• MDR Report Key: 5186156
• MDR Text Key: 29774890
• Report Number: 2124215-2015-10131
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 08/06/2015

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: 12/10/2003
• Device Model Number: 1175
• Other Device ID Number: DISCOVERY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/15/2015
• Initial Date FDA Received: 10/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2002
• 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 Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 86 YR