MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LUMAX 340 DR-T; ICD

Model Number 355267

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Hematoma (1884)

Event Date 02/24/2010

Event Type  Injury  

Event Description

The patient developed a hematoma at the wound site.This was controlled with sandbag pressure.This device currently remains implanted.There is no additional information regarding the hematoma status.

Manufacturer Narrative

The device was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device.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 which might be related to the clinical observation.In summary, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.There was no indication of a device malfunction.

• Brand Name: LUMAX 340 DR-T
• Type of Device: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-12 359; GM D-12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 3727786
• MDR Text Key: 4329227
• Report Number: 1028232-2014-01108
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 355267
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2009
• 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: 72 YR