MAUDE Adverse Event Report: CPI - DEL CARIBE ACUITY; IMPLANTABLE LEAD

Model Number 4555

Device Problems Failure to Capture (1081); Difficult To Position (1467); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2014

Event Type  Injury  

Event Description

Boston scientific received information that difficulty was encountered implanting this left ventricular lead.During the procedure, after the break away-catheter was cut away, the lead moved out the left lateral vein.Finally, the lead was successfully implanted.The following morning, this lead had increased thresholds and loss of capture in all pacing configurations.A revision procedure was performed.This lead was repositioned with difficulty and the break-away catheter was again cut away.Fluoroscopy revealed the lead had dislodged out the of the coronary sinus into the right atrium.Due to the difficulty encountered, it was thought this may be due to the coronary sinus (cs) angulation and the sharp angle of the lead entering the cs despite good lateral deep placement.A decision was made to plug the left ventricular port.A decision will be made regarding implanting another left ventricular lead in the future.No adverse patient effects were reported.

Manufacturer Narrative

According to available information, no return of product is intended.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

• Brand Name: ACUITY
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer (Section G): CPI - DEL CARIBE; guidant puerto rico b. v.; dorado PR
• Manufacturer Contact: sharon zurn ; 4100 hamline ave. n; st. paul, MN 55112 ; 6515824786
• MDR Report Key: 3718982
• MDR Text Key: 4337310
• Report Number: 2124215-2014-06885
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• 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: 03/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/17/2015
• Device Model Number: 4555
• Other Device ID Number: ACUITY STEERABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2013
• 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
• Treatment: 4136; 0292; N162; 4555
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention