MAUDE Adverse Event Report: HISTORICAL CPI ST. PAUL TRANSVENOUS; IMPLANTABLE LEAD

Model Number 4261

Device Problems Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/13/2016

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 pacemaker right atrial (ra) and right ventricular (rv) lead exhibited noise, oversensing and pacing inhibition that resulted in greater than 2 seconds of asystole.The patient was pacemaker dependent.Programming changes to sensitivity was initial attempted, however, did not resolve the observations.An invasive procedure was performed.This system was programmed vvi 40 and was left implanted on the right side for backup pacing and a new system was implanted on the left side.The physician plans to program this system off at the patient's two week follow up.No additional adverse patient effects were reported.

• Brand Name: TRANSVENOUS
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): HISTORICAL CPI ST. PAUL; guidant corporation; saint paul MN
• Manufacturer (Section G): HISTORICAL CPI ST. PAUL; guidant corporation; saint paul MN
• Manufacturer Contact: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 6250729
• MDR Text Key: 64794194
• Report Number: 2124215-2016-21156
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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: 12/13/2016

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: 02/04/1996
• Device Model Number: 4261
• Other Device ID Number: ---
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 01/13/2017
• 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: 0937; 4261; 4269; K173
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR