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

Model Number 4266

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 09/09/2014

Event Type  Death  

Event Description

Boston scientific received information that this local representative contacted boston scientific's technical services (ts) on (b)(6) 2014.The local representative was notified that this patient has an infected device and lead system.Aside from the patient's active leads, the patient has inactive leads that had been surgically capped.The local representative was inquiring about lead specifications for a possible invasive intervention.The action plan for this patient has not been determined as the local representative was enroute to consult with the physician.The device was checked and no anomalies were identified.

Event Description

Subsequently, boston scientific received information from the local representative that no invasive intervention had been undertaken.The patient had developed (b)(6) and had been given iv antibiotics for approximately one month.At some point in time, the patient was placed on comfort/palliative care.The patient died of complications related to (b)(6).

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.

• Brand Name: SENTRA
• 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 55112 ; 6515824786
• MDR Report Key: 4226413
• MDR Text Key: 5064592
• Report Number: 2124215-2014-19570
• Device Sequence Number: 1
• Product Code: DTD
• Combination Product (y/n): N
• PMA/PMN Number: K843060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4266
• Other Device ID Number: SENTRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/27/2014
• 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
• Treatment: 4266; 1550; 1600; N118; 6017; 4518; 4470; H175; 4269; 0185; 0041; 1786; 1520
• Patient Outcome(s): Death; Hospitalization; Life Threatening
• Patient Age: 72 YR