MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G151

Device Problems Low impedance (2285); Delayed Charge Time (2586); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/11/2019

Event Type  malfunction  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, visual inspection of the device identified no anomalies.Review of device memory found a shorted lead error (error code 1004) was recorded on (b)(6) 2019 at the time of the attempted implant.The device's battery status was noted to be at the beginning of life.Analysis concluded that the observed code 1004 occurred as a result of shocking into a shorted lead during the revision procedure.

Event Description

It was reported that during a revision procedure, this device was connected to the patient's implanted right ventricular (rv) lead and a test shock was delivered.Charge time was 8.6 seconds and shock impedances were low out of range, resulting in declaration of a code 1004.This device was withdrawn.A new rv lead was placed and a new pulse generator was implanted with it.No adverse patient effects were reported.

• Brand Name: DYNAGEN CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• 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: 8862505
• MDR Text Key: 153353170
• Report Number: 2124215-2019-16299
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534638
• UDI-Public: 00802526534638
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2020
• Device Model Number: G151
• Device Catalogue Number: G151
• Device Lot Number: 129850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2018
• 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 Age: 76 YR
• Patient Weight: 104