MAUDE Adverse Event Report: BOSTON SCIENTIFIC ELECTRODE

Model Number 3010

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Noise, Audible (3273)

Patient Problems Ventricular Fibrillation (2130); Shock from Patient Lead(s) (3162)

Event Date 11/03/2015

Event Type  Injury  

Event Description

Patient received multiple shocks due to "noise".First shocks began 4 days after initial implantation.Twenty eight days after initial implantation patient received a shock (described as oversensing prior to shock) due to artifact likely a connection issue.The shock actually induced vfib and required true cardioversion.Subcutaneous icd explanted on (b)(6) and replaced with second device.Patient has had a total of 7 shocks that were felt to be due to "noise" and 1 shock that was a result of vfib induced by the previous shock.

• Brand Name: ELECTRODE
• Type of Device: ELECTRODE
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 5311483
• MDR Text Key: 34152024
• Report Number: MW5058599
• Device Sequence Number: 2
• Product Code: DRF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/20/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 25 YR
• Patient Weight: 125