MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN EL ICD DR; IMPLANTABLE DEVICE

Model Number D153

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Device Displays Incorrect Message (2591); Device Sensing Problem (2917)

Patient Problems Electric Shock (2554); No Code Available (3191)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that this implantable cardioverter defibrillator (icd) declared code 1004 which is indicative of shorted circuit condition detected during shock delivery.The right ventricular (rv) lead is a non-boston scientific lead.The rv lead exhibited noise and oversensing that resulted in delivery of inappropriate shock therapy.Post inappropriate shock delivery, device therapy was turned off until the generator could surgically be replaced.Noise on the rv lead was able to be replicated through isometric manipulation movements.An invasive procedure was performed.The icd was replaced and the rv lead was surgically abandoned.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN EL ICD DR
• Type of Device: IMPLANTABLE DEVICE
• 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: 9549814
• MDR Text Key: 173694180
• Report Number: 2124215-2019-26343
• 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
• Report Date: 01/04/2020

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: 09/02/2017
• Device Model Number: D153
• Device Catalogue Number: D153
• Device Lot Number: 201723
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 01/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 58 YR