MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG COROX OTW-L 75-BP; LV LEAD

Model Number	368345
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Early battery depletion.Generator change was scheduled, but when opening the pocket, debris was found in pocket, therefore a device and lead extraction followed.The complaint concerning the icd was reviewed and the attention was focused on the leads.
Additional Manufacturer Narrative
The leads under complaint were not returned for investigation.Therefore the inspection is solely based on the analysis of the icd itself.The device was received and analyzed.The memory content of the icd was inspected, showing a normal device function while implanted and in service.The battery status of the icd was eri.The amount of charge taken from the battery was verified and the battery condition was anticipated.The icd was subjected to an electrical analysis.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and 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.Besides the eri complaint, an infection was reported following the implantation of these biotronik devices.The sterilization process was investigated.The validated process assures that all sterilization parameters, such as gas concentration, temperature, humidity, etc., are within its specified ranges for each distributed device.Additionally an analysis of validated microbiological indicators is performed after every sterilization procedure as evidence of successful completion of the sterilization process.Review of the biotronik complaint database did not reveal any changes regarding the trend for this type of incident.In conclusion, the infection was not device related.Furthermore the icd proved to be fully functional and the battery status was anticipated.There was no indication of an icd malfunction.

• Brand Name: COROX OTW-L 75-BP
• Common Device Name: LV LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10864505
• Report Number: 1028232-2020-05036
• Device Sequence Number: 11402806
• Product Code: OJX
• UDI-Device Identifier: 04035479112165
• UDI-Public: 04035479112165
• Combination Product (Y/N): N
• PMA/510(K) Number: P070008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2014
• Device Model Number: 368345
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 11/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization