MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; PROGRAMMER, PACEMAKER

Model Number T175

Device Problem Defective Device (2588)

Patient Problems No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)

Event Date 01/01/2008

Event Type  Injury  

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.

Event Description

Boston scientific received information that this the patient's implantable cardioverter defibrillator (icd) was turned off but was left in place.This icd remains in service.No adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient's implantable cardioverter defibrillator (icd) was turned off but was left in place.This icd remains in service.No adverse patient effects were reported.Additional information received indicated that the device has not been working for several years and the leads have actually fractured as the patient has grown.The device together with the leads will be removed.No adverse patient effects were reported.

Event Description

It was reported that the patient's implantable cardioverter defibrillator (icd) was turned off but was left in place.Additional information received indicated that the device has not been working for several years and the leads have actually fractured as the patient has grown.The device together with the leads will be removed.Moreover, during system extraction, it was found out that the patient had a non-boston scientific device.The field representative stated that this icd was replaced at some unknown time.Device and leads were removed from the patient.No additional adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.

• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8316807
• MDR Text Key: 135414331
• Report Number: 2124215-2019-02719
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• PMA/PMN Number: P960040/S039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/02/2005
• Device Model Number: T175
• Device Catalogue Number: T175
• Device Lot Number: 100224
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR