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

Model Number 4554

Device Problems Pocket Stimulation (1463); Capturing Problem (2891)

Patient Problem Muscle Stimulation (1412)

Event Date 10/17/2008

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 that the left ventricular (lv) lead was surgically abandoned due to an unspecified product performance issue.Additional information indicated that the lv lead exhibited high pacing threshold and caused muscle stimulation.Moreover, diaphragmatic stimulation was noted since implant and threshold rose over time.A new lead was then implanted.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: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7990431
• MDR Text Key: 124520665
• Report Number: 2124215-2018-19040
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/09/2010
• Device Model Number: 4554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2008
• 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: 0185; 4136; 4554; N119
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 64 YR