MAUDE Adverse Event Report: EXTERNAL MANUFACTURER PROGRAMMER

Model Number 3300

Device Problems Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2018

Event Type  malfunction  

Manufacturer Narrative

Following return and completion of laboratory analysis, this event will be further updated.

Event Description

Boston scientific received information that during the post implant review, the programmer in use exhibited an error code.Reportedly at the time, the patient was showing an episode which looked to be a repetitive non re-entrant ventriculoatrial synchrony on the presenting electrogram, which correlated to the av search algorithm extended av delay.The error code was then exhibited as the user/operator was attempting to programmer off, the av search programming feature.Another programmer of a different model type was required to completed the desired programming change; all other measurements and parameters were confirmed normal.Engineers stated the error code was off a general nature, thus undescriptive of any identified malfunctions.The programmer exhibiting the error code is expected to be returned for analysis.The patient was symptomic during the high rate pacing however enclear if due to an implant sedation side effect or the obseved tachycardia.

Manufacturer Narrative

Upon receipt, the programmer underwent functional testing.The programmer was powered on to check for error reports or boot-up issues.No anomalies were noted.Next, a test device was interrogated several times, confirming there were no communication problems between the device and programmer.Several induced damages were observed and the corresponding parts replaced.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities; the programmer performed normally throughout all tests.The root cause was believed to be a software issue which was unable to be duplicated during analysis.

• 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: 7463946
• MDR Text Key: 106624903
• Report Number: 2124215-2018-05890
• Device Sequence Number: 1
• Product Code: OSR
• Combination Product (y/n): N
• 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: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2017
• 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