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

Model Number T135

Device Problem Defective Device (2588)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this implantable cardioverter defibrillator (icd) was not functional.Healthcare professional (hcp) asked boston scientific technical services (ts) if the device is magnetic resonance imaging (mri) conditional.Ts then confirmed device is not mri conditional.To date, the device remains in service.No adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.The device has been received for analysis and upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a medwatch report will be filed.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) was not functional.Health care professional (hcp) asked boston scientific technical services (ts) if the device is magnetic resonance imaging (mri) conditional.Ts then confirmed device is not mri conditional.To date, the device remains in service.No adverse patient effects were reported.Additional information was received indicating that the device was explanted and was returned to the laboratory for further analysis.No additional adverse patient effects were reported.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) was not functional.Health care professional (hcp) asked boston scientific technical services (ts) if the device is magnetic resonance imaging (mri) conditional.Ts then confirmed device is not mri conditional.To date, the device remains in service.No adverse patient effects were reported.Additional information was received indicating that the device was explanted and was returned to the laboratory for further analysis.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.The device has been received for analysis and upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a medwatch report will be filed.Upon receipt at our post market quality assurance laboratory, an ohm meter was used to verify that the defibrillation output bridge was intact.Resistance across the df+ to the df- was measured at 132.7 kohms, which is normal, and confirms that the output bridge is intact and therapy availability was not compromised.Manual therapy availability testing was unable to be performed, as the device has reached bex due to a normally depleted battery.No allegation from the field has been made against device functionality at explant.The device has been implanted for approximately 16.7 years; far exceeding nominal expected longevity.Supplemental correction to correction section h1 type of reportable event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.The device has been received for analysis and upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a medwatch report will be filed.Upon receipt at our post market quality assurance laboratory, an ohm meter was used to verify that the defibrillation output bridge was intact.Resistance across the df+ to the df- was measured at 132.7 kohms, which is normal, and confirms that the output bridge is intact and therapy availability was not compromised.Manual therapy availability testing was unable to be performed, as the device has reached bex due to a normally depleted battery.No allegation from the field has been made against device functionality at explant.The device has been implanted for approximately 16.7 years; far exceeding nominal expected longevity.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) was not functional.Health care professional (hcp) asked boston scientific technical services (ts) if the device is magnetic resonance imaging (mri) conditional.Ts then confirmed device is not mri conditional.To date, the device remains in service.No adverse patient effects were reported.Additional information was received indicating that the device was explanted and was returned to the laboratory for further analysis.No additional adverse patient effects were reported.

• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 11104162
• MDR Text Key: 225094867
• Report Number: 2124215-2020-25799
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/05/2004
• Device Model Number: T135
• Device Catalogue Number: T135
• Device Lot Number: 932303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2003
• 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): Required Intervention; Hospitalization
• Patient Age: 45 YR
• Patient Sex: Female