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

Model Number T177

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2019

Event Type  Injury  

Manufacturer Narrative

As no further information regarding this event is expected, our investigation is complete.This report will be updated should additional information be provided.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) exhibited code 01 - which is indicative of a charge time out.The icd was observed to be at end of life and device replacement was recommended.At this time the icd remains implanted and in service.No adverse patient effects were reported.

Manufacturer Narrative

This product has been returned back from the field for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) exhibited code 01 - which is indicative of a charge time out.The icd was observed to be at end of life and device replacement was recommended.At this time the icd remains implanted and in service.No adverse patient effects were reported.Additional information indicated surgical intervention was later performed and the icd was explanted.No additional adverse patient effects were reported.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) exhibited code 01 - which is indicative of a charge time out.The icd was observed to be at end of life and device replacement was recommended.At this time the icd remains implanted and in service.No adverse patient effects were reported.Additional information indicated surgical intervention was later performed and the icd was explanted.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.External visual inspection noted tool marks on the header.The device case was observed to be slightly swollen but this is normal with battery depletion.The device was interrogated and the battery status was found to be at end of life (eol).The device passed longevity calculations.A review of the device memory noted a charge time fault.The fault occurred after seven successful full energy shock deliveries in a 24 hour period two months after eol had been set.This is normal device operation.Analysis determined the device met specification and was depleting normally.

• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9270246
• MDR Text Key: 164858838
• Report Number: 2124215-2019-23434
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/17/2009
• Device Model Number: T177
• Device Catalogue Number: T177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Date Manufacturer Received: 09/24/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening