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

Model Number D150

Device Problems Pocket Stimulation (1463); Unexpected Therapeutic Results (1631); Patient-Device Incompatibility (2682)

Patient Problems Muscle Stimulation (1412); Unspecified Infection (1930); Sepsis (2067); Ventricular Tachycardia (2132); Dizziness (2194); Cardiac Perforation (2513)

Event Date 10/26/2018

Event Type  Injury  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental report will be filed.

Event Description

Boston scientific received information that the patient with this implantable cardioverter defibrillator (icd) device received shock and anti-tachycardia pacing (atp) therapies for true ventricular tachycardia (vt) episode.The patient also felt stimulation with pacing and atp.Moreover, it was noted that the patient was a little dizzy but did not pass out.Additional information indicated that the icd was explanted due to infection with sepsis and perforation in the heart wall.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN EL ICD VR
• 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 CLONMEL LIMITED; cashel road; ,; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8318741
• MDR Text Key: 135491905
• Report Number: 2124215-2019-02892
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526534287
• UDI-Public: 00802526534287
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2019

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: 08/08/2020
• Device Model Number: D150
• Device Catalogue Number: D150
• Device Lot Number: 241527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2018
• 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; Life Threatening; Required Intervention
• Patient Age: 57 YR