MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LUMAX 540 DR-T; ICD

Model Number 360346

Device Problem Programming Issue (3014)

Patient Problems Fatigue (1849); Pain (1994); Discomfort (2330)

Event Date 08/04/2014

Event Type  Injury  

Event Description

Ous mdr - it was reported to us that the device was programmed in a way causing av-dyssynchrony (vvi 60 bpm) since (b)(6) 2014.Furthermore, the patient reportedly had symptoms like chest pain, fatigue and feeling bad in general.The programming was changed to ddd 60 bpm.The date of implant was not provided.

Manufacturer Narrative

We received the event description for the above mentioned device and would like to thank you for supporting our post-market surveillance.As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The information you provided has been entered into our quality system as a complaint.These types of complaints are used to evaluate systems and device performance throughout our organization and help to maintain and improve the performance of our devices.As neither the device, nor any device data were returned, the analysis is limited to the inspection of the quality documents associated with the manufacture of this particular device.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process which might be related to the clinical observation.

• Brand Name: LUMAX 540 DR-T
• Type of Device: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 4281104
• MDR Text Key: 5225532
• Report Number: 1028232-2014-005944
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P000009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 360346
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2011
• 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 Outcome(s): Other