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

Model Number 4555

Device Problems Failure to Capture (1081); Device Dislodged or Dislocated (2923)

Patient Problems Syncope (1610); Fall (1848)

Event Date 12/01/2014

Event Type  Injury  

Event Description

Boston scientific received information that the patient went to the hospital due to losing consciousness and not feeling well after he took a fall while riding his bike.An x-ray concluded a clavicle fracture and the left ventricular (lv) lead had dislodged.Additionally high thresholds were observed on the lv lead and it was noted there was an occlusion restricting access to the lead.As a result the lead was capped and replaced.No further adverse patient effects were reported.

Manufacturer Narrative

(b)(4).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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN 55112 ; 6515824786
• MDR Report Key: 4399992
• MDR Text Key: 20733248
• Report Number: 2124215-2014-21072
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• PMA/PMN Number: P050046
• 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: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/23/2014
• 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
• Initial Date Manufacturer Received: 12/01/2014
• Initial Date FDA Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2012
• 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: 4592; 4555; 4097; W173; 4096
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention