MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LUMAX 740 HF-T; CRT-D

Model Number 365608

Device Problem Difficult to Interrogate (1331)

Patient Problem Twiddlers Syndrome (2114)

Event Date 01/29/2014

Event Type  malfunction  

Event Description

This device was explanted and replaced because it delivered a 28j shock, but failed to deliver a max energy shock that was programmed.This device could not be reinterrogated after this.Later insulation damage was noted on the rv lead.The lv lead had become dislodged due to twiddler's syndrome, and the physician felt this might have contributed to the rv lead issue.Should additional information be received, this file will be updated.

Manufacturer Narrative

The returned icd could not be interrogated, confirming the clinical observation.Therefore, the device was opened to inspect the inner assembly and to check the functionality of the electronic module.During the inspection of the electrical module, the analysis revealed that the fuse separating the battery from the electronic module as well as the output stages of the high voltage circuit had been damaged.Due to this damage of the electronic module, the device could not be interrogated properly.The battery voltage amounted to 3.12 v, demonstrating that the battery was not depleted.Based on the damage symptoms of the electronic module, the icd was damaged due to a shock delivery of the icd into an external short circuit after the detection of ventricular tachycardia.Possible clinical complications that might lead to an external short circuit include, but are not limited to, twiddler's syndrome, a subclavian crush syndrome or other lead insulation damages.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 observed damage symptoms.Particularly the final acceptance test proved the device functions to be flawless.

• Brand Name: LUMAX 740 HF-T
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-12 359; GM D-12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 3630369
• MDR Text Key: 3991502
• Report Number: 1028232-2014-00454
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/04/2014

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: 365608
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2015
• Initial Date FDA Received: 02/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2013
• 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
• Patient Age: 82 YR