MAUDE Adverse Event Report: GUIDANT PUERTO RICO BV ACUITY; IMPLANTABLE LEAD

Model Number 4555

Device Problems Pocket Stimulation (1463); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Stimulation (1412); Unspecified Infection (1930)

Event Date 01/12/2016

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 this product was part of a system revision due to infection.It was also noted that this left ventricular (lv) lead was repaired due to insulation damage.In addition muscle stimulation was previously noted when the patient was lying on their left side, thus was programmed off due to pectoral twitching.There were no additional adverse effects reported.

• Brand Name: ACUITY
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): GUIDANT PUERTO RICO BV
• Manufacturer (Section G): GUIDANT PUERTO RICO BV
• Manufacturer Contact: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5596212
• MDR Text Key: 43271091
• Report Number: 2124215-2016-01015
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P050046/S000
• 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: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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
• Date Manufacturer Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention