MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LUMAX 540 HF-T; CRT-D

Model Number 360347

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

Patient Problems Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Patient Problem/Medical Problem (2688)

Event Date 06/06/2012

Event Type  Injury  

Event Description

The patient presented for a generator change.During the procedure, he became markedly hypotensive and was nonresponsive to chemical resuscitation.External chest compressions were started.Generator change was able to be completed, an intra-aortic balloon pump was placed, and the patient was transferred to the icu in critical condition.Patient noted to have expanding hematoma at icd site same day as generator change with profound hemodynamic collapse requiring chest compressions.The hematoma was evacuated under general anesthesia.The patient once again had hemodynamic collapse and required cpr while intravenous pressors were administered.He was transferred back to the icu.Antihypertensive medications were slowly reintroduced and the intra-aortic pump was removed 24 hours later.He was discharged home in good condition on (b)(6) 2012.This device currently is still implanted and no further adverse patient side effects were reported.

Manufacturer Narrative

We received your event description for the above mentioned device and would like to thank you for supporting our post-market surveillance.The device is currently not available for analysis.Therefore, no conclusion can be drawn at this time.However, biotronik monitors the post-market performance of its products closely in order to identify any trends that may reveal over time a potential manufacturing or design issue.The historic performance of the product involved in the current case does not at this point reveal any such trend.Should additional relevant information become available, this investigation will be updated.

• Brand Name: LUMAX 540 HF-T
• 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: 6292727
• MDR Text Key: 66247480
• Report Number: 1028232-2017-00231
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 360347
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2011
• 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: 66 YR