MAUDE Adverse Event Report: EXTERNAL MANUFACTURER PROGRAMMER

Model Number 3300

Device Problems Pacing Problem (1439); Capturing Problem (2891)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2017

Event Type  malfunction  

Manufacturer Narrative

The programmer remains available for use.It was suspected the issue of the psa pacing in the rv when ra pacing was commanded was due to bad psa cables or incorrect connections to the lead.The field representative confirmed the cables had been exchanged and reconnected, and they were not able to recreate the observation after proper ra pacing was obtained.The field representative also confirmed the threshold measurements were taken with the boston scientific psa and the competitor's psa with no changes to pacing vectors or lead position, and for all leads the difference was approximately 1v.For future implant cases, the hospital planned to test lead measurements with both psas.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 programmer's pacing system analyzer (psa) feature was used during an implant procedure.The physician made two observations about the programmer's psa.First, during testing for the right atrial (ra) lead, the psa cables were properly connected to the right ventricular (rv) and ra leads.However, when the field representative commanded the psa to pace in the ra, the stimulation was observed in the rv.This happened a second time, until suddenly the ra lead was pacing as expected.Due to this anomaly, another manufacturer's psa was used to test the measurements of all leads.It was then observed that the pacing threshold measurements with the competitor's psa were approximately 1v less than the threshold measurements with the boston scientific psa.When the leads were tested with the implanted cardiac resynchronization therapy pacemaker (crt-p), the threshold measurements were consistent with the non-boston scientific psa.The physician complained that the mismatch in threshold values was responsible for prolonging the procedure, as the initial left ventricular (lv) lead was removed and replaced due to high pacing threshold measurements.A clinical decision was made to change the lead based on the measurements from the boston scientific psa.No adverse patient effects were reported, and the crt-p system was implanted successfully.

• Brand Name: PROGRAMMER
• Type of Device: PROGRAMMER
• Manufacturer (Section D): EXTERNAL MANUFACTURER
• Manufacturer (Section G): EXTERNAL MANUFACTURER
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 6995741
• MDR Text Key: 91206068
• Report Number: 2124215-2017-19933
• Device Sequence Number: 1
• Product Code: OSR
• Combination Product (y/n): N
• Reporter Country Code: ES
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3300
• Other Device ID Number: LATITUDE PROGRAMMER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2017
• 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: 72 YR