MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LUMAX 540 HF-T; CRT-D

Model Number 360347

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/20/2015

Event Type  malfunction  

Event Description

Ous mdr.An eos alert was sent via home monitoring regarding this patient's crt-d.The patient was brought in for an appointment where it was discovered an mri had been performed and cardiology had not been contacted even though the patient told the radiologist about the device.The patient had a revision done and this device was removed.The leads showed no abnormalities in measurements and on fluoroscopy.

Manufacturer Narrative

The icd first underwent a status interrogation, during which the device status eos was confirmed.The icd had been implanted for a period of 36 months, and 19 charge processes were documented.During the electrical analysis, the memory content of the icd was examined first.The available iegm from (b)(6) 2015 showed interference signals in all channels.In addition, it was noted that the battery status eos was detected on the same day at 11:01 a.M.The frequency and morphology of the sensed interference signals, as well as the eos detection, are with high probability the result of the influence of a strong external magnetic field, which indicates the beginning of the reported magnetic resonance tomography.The signal sensing of the icd was checked and proved to be free of noise.The icd sensed supplied signals free of interference.The eos state was removed with a technical programmer, and the device then showed the state mol1.The battery voltage of 2.87 v indicates a charged battery.The icd's capability to provide therapy was tested.The antibradycardic output signal was normal and matched the programmed values.A fibrillation signal was supplied, and the device reacted according to specifications with a defibrillation shock.The specified energy level was reached.In particular, the charge time proved to be unremarkable.There were no indications of a device malfunction, the device proved to be fully functional.In summary, the therapeutic functions and the device data were thoroughly analyzed.During the analysis, the implant proved to be within the electrical specifications.There was no indication of a device malfunction.It is therefore very likely that the observed device behavior resulted from the influence of the strong external magnetic field during the magnetic resonance tomography.

• Brand Name: LUMAX 540 HF-T
• Type of Device: CRT-D
• 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: 5358176
• MDR Text Key: 35615225
• Report Number: 1028232-2015-04762
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 360347
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/18/2015
• Initial Date FDA Received: 01/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2012
• 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): Hospitalization