MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILESTO 7 HF-T DF-1; CRT-D

Model Number 383547

Device Problem Failure to Interrogate (1332)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 09/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

A cardioversion was performed on the device.After the cardioversion, the programmer was unable to make any connection to the device.There were no light on the wand when placed over the device.Another programmer was tried with the same response.Device was explanted, but has not been returned for analysis.Ca.

Manufacturer Narrative

The icd was subjected to an electrical analysis, revealing that the device could not be interrogated, confirming the clinical observation.Therefore, the icd was opened and the inner assembly was inspected.During the inspection of the electronic 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.Based on the damage symptoms of the electronic module, the device was most probably damaged due to a shock delivery of the icd into an external short circuit.Possible clinical complications that might lead to an external short circuit include - butare not limited to - a twiddler syndrome, a subclavian crush syndrome or other lead insulation damages.Therefore a potential damage of the icd lead used with this device should be taken into consideration.In a next step, 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.Particularly the final acceptance test proved the device functions to be as specified.In conclusion, the electronic module was found damaged most probably due to a shock delivery into an external short circuit.Due to the damages the device could not be interrogated properly.The analysis revealed no indication of a material or manufacturing problem.

• Brand Name: ILESTO 7 HF-T DF-1
• 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: 5137591
• MDR Text Key: 27826018
• Report Number: 1028232-2015-03647
• 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
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 09/28/2015

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: 383547
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2014
• 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: 67 YR