MAUDE Adverse Event Report: GUIDANT ANGLETON/ST. PAUL DASH; IMPLANTABLE PULSE GENERATOR

Model Number 292-03

Device Problem Reset Problem (3019)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/23/1998

Event Type  Injury  

Manufacturer Narrative

The product has been received for analysis over 17 years later.This report will be updated upon completion of analysis.

Event Description

Boston scientific received information that this pacemaker had an electrical reset and the device went into safety mode.The device was explanted about five months later.No details were provided regarding the explant.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was unable to be performed due to low battery voltage.

• Brand Name: DASH
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): GUIDANT ANGLETON/ST. PAUL; intermedics; angleton TX
• Manufacturer (Section G): GUIDANT ANGLETON/ST. PAUL; intermedics; angleton TX
• Manufacturer Contact: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 6464566
• MDR Text Key: 71894550
• Report Number: 2124215-2017-03896
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 292-03
• Other Device ID Number: DASH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/14/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: 292-03; 430-07
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 80 YR