MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG EVIA DR-T; PACEMAKER

Model Number 359529

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

Patient Problem Reaction (2414)

Event Date 09/22/2014

Event Type  Injury  

Event Description

The patient has had an allergic reaction at the pacer site accompanied by redness and itching.This is all of the information that was provided at this time.Should additional information become available, this event will be updated.

Manufacturer Narrative

An allergic reaction 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 conclusion, the allergic reaction was not device related.

• Brand Name: EVIA DR-T
• Type of Device: PACEMAKER
• 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: 4332958
• MDR Text Key: 5146284
• Report Number: 1028232-2014-006050
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2014

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
• Device Operator: Health Professional
• Device Model Number: 359529
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2014
• Initial Date FDA Received: 12/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2013
• 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: 73 YR