MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN EL ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number D153

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Death (1802); No Known Impact Or Consequence To Patient (2692)

Event Date 09/25/2019

Event Type  Death  

Manufacturer Narrative

The local area field representative was contacted for additional information.This investigation will be updated should further information be provided.

Event Description

It was reported that at a device check this implantable cardioverter defibrillator (icd), implanted with another manufacturers defibrillation lead, exhibited three codes on device interrogation.The codes indicated a shock lead short, a high voltage detection during charge repeat, and that the charge time was exceeded.Boston scientific technical services (ts) discussed the device attempted to deliver a shock however due to a potential lead issue the energy found an alternative pathway and likely damaged the device.Device replacement was recommended as therapy may not be available.No adverse patient effects were reported.

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

It was reported that at a device check this implantable cardioverter defibrillator (icd), implanted with another manufacturers defibrillation lead, exhibited three codes on device interrogation.The codes indicated a shock lead short, a high voltage detection during charge repeat, and that the charge time was exceeded.Boston scientific technical services (ts) discussed the device attempted to deliver a shock however due to a potential lead issue the energy found an alternative pathway and likely damaged the device.Device replacement was recommended as therapy may not be available.No adverse patient effects were reported.Additional information was received indicating the patient expired a couple days after the codes were displayed.No further information was available.

• Brand Name: DYNAGEN EL ICD DR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 9274669
• MDR Text Key: 164921135
• Report Number: 2124215-2019-23760
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526534829
• UDI-Public: 00802526534829
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

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: 01/22/2018
• Device Model Number: D153
• Device Catalogue Number: D153
• Device Lot Number: 203407
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 11/04/2019
• Supplement Dates Manufacturer Received: 10/25/2019
• Supplement Dates FDA Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2016
• 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): Death; Life Threatening
• Patient Age: 74 YR