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

Model Number 4260

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2016

Event Type  malfunction  

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 while hospitalized for an unrelated cause, the patient implanted with this system experienced a heart rate of 20 bpm per external electrocardiogram but was noted to be asymptomatic.The device was interrogated and noise with oversensing was observed in both bipolar and unipolar configurations.Device sensitivity was reprogrammed but did not resolve the issue.Review of lead measurements noted they were consistent with past values.The patient was provided a temporary pacemaker and a procedure performed the following day wherein a new system was implanted on the side opposite their existing device and the chronic system was abandoned.No 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: 5823819
• MDR Text Key: 51187335
• Report Number: 2124215-2016-11660
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• PMA/PMN Number: K822458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/14/1992
• Device Model Number: 4260
• Other Device ID Number: ---
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/29/2016
• 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 Age: 91 YR