MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILESTO 7 HF-T PROMRI DF4; CRT-D

Model Number 390061

Device Problem Failure to Interrogate (1332)

Patient Problem Twiddlers Syndrome (2114)

Event Date 11/15/2018

Event Type  Injury  

Event Description

Ous mdr - after an implantation period of approx.34 months, it was reported that the icd could not be interrogated.Furthermore, suspected twiddler syndrome was observed.No adverse patient side effects have been reported.The device and the rv lead were explanted.

Manufacturer Narrative

Only the icd and the rv-lead were returned for analysis.The investigation is therefore based on the inspection of the quality documents associated with the manufacture of these devices as well as on the analysis of the icd and the rv lead themselves.The manufacturing process of these devices 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 icd functions to be as specified.Upon initial inspection the icd could not be interrogated, confirming the clinical observation.The analysis revealed that this resulted from a damage of the electronic module, most probably due to a shock delivery into an external short circuit.It cannot be excluded that the reported twiddler syndrome led to this observation.The returned rv lead was inspected showing multiple cuts in the insulation with blood infiltration most likely resulting from the explantation procedure.Furthermore the shock coil was deformed which also presumably occurred during the extraction procedure.The analysis revealed no indication of a material or manufacturing problem of these devices.

• Brand Name: ILESTO 7 HF-T PROMRI DF4
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• MDR Report Key: 8292630
• MDR Text Key: 134589755
• Report Number: 1028232-2019-00288
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 390061
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization