MAUDE Adverse Event Report: CPI PLANT - ST. PAUL ACUITY; IMPLANTABLE LEAD

Model Number 4674

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

Patient Problems Muscle Stimulation (1412); Pericardial Effusion (3271)

Event Date 12/31/2015

Event Type  Injury  

Manufacturer Narrative

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

Boston scientific received information from a clinical study that this left ventricular (lv) lead presented with diaphragm stimulation.The lv lead was programmed off and the patient was to be seen again at a later date for further testing.No adverse patient effects were reported.Additional information was later received that the clinical site determined that the lead had dislodged, which was caused the diaphragm stimulation.A revision procedure was performed and this lv lead was explanted and successfully replaced.Following the procedure, the patient experienced a pericardial effusion.The patient was hospitalized but no interventions were performed.The clinical site also reported that the effusion was not related to the leads.The new lead remains implanted and in service.No additional adverse patient effects were reported.

• Brand Name: ACUITY
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): CPI PLANT - ST. PAUL; guidant corporation; saint paul MN
• Manufacturer (Section G): CPI PLANT - ST. PAUL; guidant corporation; saint paul MN
• Manufacturer Contact: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5787188
• MDR Text Key: 49332373
• Report Number: 2124215-2016-07859
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/25/2017
• Device Model Number: 4674
• Other Device ID Number: ACUITY X4 SPIRAL S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2015
• 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: 4674
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention