MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LUMAX 340 HF-T; CRT-D

Model Number 355263

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Ambient Noise Problem (2877)

Patient Problems Patient Problem/Medical Problem (2688); Shock from Patient Lead(s) (3162)

Event Date 03/30/2015

Event Type  malfunction  

Manufacturer Narrative

Upon receipt, the icd was interrogated, revealing the battery status mol2.The device was implanted for 95 months and 44 charging cycles were recorded to the device memory.The memory content of the device was inspected.During analysis of the available iegms noise was observed in the right ventricular channel, leading to multiple charging cycles that partially resulted in shock delivery, confirming the clinical observation.Besides that, the device data showed no conspicuities.Especially the trend of the recorded impedances was normal and as expected.In a next step, a sensing test was performed.The device sensed the attached heart signals free of noise, proving the sensing function of the icd to be fully functional.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal in amplitude and frequency as programmed.A fibrillation signal was applied and the device delivered a defibrillation shock as specified, documenting a correct sensing and shock delivery.In particular, the specified energy level was reached.In conclusion, the memory content as well as the therapeutic functionality of the icd were inspected.In the available iegms the occurrence of noise was observed in the right ventricular channel, leading to multiple shock deliveries as reported in the complaint description.Besides that, the device data showed a normal and as expected device behavior.A thorough analysis of the icd functionality proved the device to be fully functional.There was no indication of a device malfunction.

Event Description

Ous mdr - on the (b)(6) 2015, the patient arrived to the clinic after receiving 4 shocks due to noise on the rv channel.The rv lead parameters showed a slight change in the impedance and in the pacing threshold.Update 04/30/2015: after speaking with the patient during clinic, we discovered that he had undergone an mri a few months prior to device interrogation.Neither the device nor the leads were mri compatible.Additionally, the device was not interrogated immediately prior to or after the mri.The old rv lead was capped and replaced with a new rv lead, and the device was replaced as well.

• Brand Name: LUMAX 340 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: 5212686
• MDR Text Key: 30836593
• Report Number: 1028232-2015-04021
• 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
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 355263
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2007
• 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