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

Model Number 4555

Device Problems Failure to Capture (1081); Fracture (1260); High impedance (1291); Sensing Intermittently (1558); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2014

Event Type  Injury  

Event Description

Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) with this left ventricular (lv) lead exhibited intermittent sensing with loss of capture (loc) that lead to less than two seconds of asystole.An insulation and conductor damage with increase in pacing lead impedance measurement of more than 2,000 ohms were also noted.Additional information was received that the lead defect was confirmed through visual inspection and was not tested with a psa.No other adverse patient effects were reported.The device remains in service while the lead was partially abandoned and was out of service.

Manufacturer Narrative

(b)(4).Upon receipt at our post market quality assurance laboratory, portion of the lead was evaluated and revealed fracture 363 millimeters from the terminal pin.Conductor coils were deformed and there were cuts on the insulation.Melted insulation from the laser extraction tool was also noted.Insulation and conductor damage was confirmed.

• 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN 55112 ; 6515824786
• MDR Report Key: 3916435
• MDR Text Key: 4491552
• Report Number: 2124215-2014-11122
• 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: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2010
• Device Model Number: 4555
• Other Device ID Number: ACUITY STEERABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2008
• 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: H217; N141; 4555; 4470; 0158
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 66 YR