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

Model Number 4554

Device Problems Pocket Stimulation (1463); Capturing Problem (2891); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2014

Event Type  Injury  

Event Description

Boston scientific received information that this left ventricular (lv) lead was dislodged.Subsequently, the physician repositioned the lead.This lv lead remains in service.No additional 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.

Manufacturer Narrative

Per field representative's reply, this device was kept by the hospital.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Additional information from the field representative indicated that this left ventricular (lv) lead probably exhibited high thresholds or stimulation.This lv lead was explanted.No additional adverse patient effects were reported.

• 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: 4400288
• MDR Text Key: 5368875
• Report Number: 2124215-2015-00095
• Device Sequence Number: 1
• Product Code: NVY
• 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,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

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: 07/03/2016
• Device Model Number: 4554
• 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: 12/09/2014
• Initial Date FDA Received: 01/08/2015
• Supplement Dates Manufacturer Received: 12/20/2017
• Supplement Dates FDA Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2014
• 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: N160; 0292; 4469; 4554
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 62 YR