MAUDE Adverse Event Report: IPG MFG SWITZERLAND VITATRON DA+ T-SERIES SR; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

Model Number T20A1U

Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591); Reset Problem (3019)

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

Event Date 02/15/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).

Event Description

It was reported that during implantable pulse generator (ipg) follow up check, all the lead and battery measurements were fine but when the device was interrogated there was no diagnostic data available such as percentage paced and sensed, the histograms were blank and the therapy advisor was not available due to insufficient data.Interrogating was attempted again, switched the programmer off and on again but no change.Evaluation of occurrence indicated a power on reset (por) occurred.The ipg recovered correctly, and remains in use.Patient will be monitored during subsequent follow up visits.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was not returned for analysis.However, performance data collected from the device was received and analyzed.Analyst commented, bit flip in address 0x1e0f, an area of code referencing a diagnostic buffer, which would lead to missing diagnostic data.

Event Description

It was further reported via additional information received that a flip-bit issue occurred.A flipped bit is a soft error that might occur during radiation therapy but also in some special cases during normal background radiation.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: VITATRON DA+ T-SERIES SR
• Type of Device: PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer (Section G): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5556644
• MDR Text Key: 42765109
• Report Number: 9614453-2016-02029
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P990001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/28/2007
• Device Model Number: T20A1U
• Device Catalogue Number: T20A1U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2006
• 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: 00089 YR