MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG COROX OTW-L 85-BP; LV LEAD

Model Number 368346

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Unspecified Infection (1930)

Event Date 09/15/2016

Event Type  Death  

Event Description

It was reported that this patient was admitted to the er on (b)(6) 2016 for sepsis and infection.Shortly after the patient was admitted, the patient needed to be intubated secondary to worsening mental status and labored respiration.About 30-45 minutes after intubation, a code blue was called.The patient was resuscitated after medication was given and cpr performed.The patient also received 2 appropriate icd shocks.Shortly after the code was completed and the patient stabilized, it was noted that his mild hyperkalemia of 5.7 had risen to 8.6 likely causing the instability and cardiac arrhythmia.The physician had a quinton dialysis catheter placed to start emergent hemodialysis.On (b)(6) 2016 it was noted that the patient had a cardiac arrest.The patient was mostly non-responsive but did have a cranial nerve reflex intact and was on a ventilator.On (b)(6) 2016 the family decided to follow the dnr and the patient was removed from life support and expired.The discharge diagnoses listed septic shock secondary to pneumonia, cardiopulmonary arrest, shock liver, acute hypoxic respiratory failure.Should additional information be received, this file will be updated.

Manufacturer Narrative

An infection was observed following the implantation of this biotronik device.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 summary, the infection was not device related.

• Brand Name: COROX OTW-L 85-BP
• Type of Device: LV LEAD
• 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: 7793359
• MDR Text Key: 117469370
• Report Number: 1028232-2018-02938
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 40354791121720
• UDI-Public: (01)40354791121720
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 368346
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2015
• 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): Death
• Patient Age: 74 YR