MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE; PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 0185

Device Problems Fracture (1260); Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problems Congestive Heart Failure (1783); Left Ventricular Dysfunction (1947)

Event Date 11/16/2016

Event Type  malfunction  

Event Description

Notes from the operative report: indications: the patient with history of congestive heart failure and ischemic cardiomyopathy who had a dual-chamber aicd (automatic implantable cardioverter-defibrillator) implanted in 2005.The device has reached its eri.He has severe left ventricular systolic dysfunction, lvef 20% (left ventricular ejection fraction).He has a malfunctioning icd lead.He also has a left bundle branch block with qrs duration of 160 milliseconds.He has class ii symptoms of congestive heart failure for more than five years.Laser lead extraction of aicd lead: existing aicd lead was a guidant model #0185119982.On fluoroscopy, it appeared to be fractured near the proximal coil.The lead was dissected down to the anchoring sleeve.Clear ring was placed within the body of the lead.An ez locking stylet was placed within the distal tip of the lead.A number 0 silk was placed over the insulation.A 14-french laser sheath was used and using traction countertraction maneuvers, the lead was removed intact from the body.Underwent successful laser lead extraction and upgrade to biventricular aicd.The patient tolerated the procedure well with no complication.

• Brand Name: RELIANCE
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline ave n; saint paul MN 55112
• MDR Report Key: 6240606
• MDR Text Key: 64451063
• Report Number: 6240606
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0185
• Other Device ID Number: GUIDANT 0185
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/22/2016
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 95