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 Pain (1994)

Event Date 08/08/2014

Event Type  Injury  

Event Description

The patient has had some pain around the pocket site since implant on (b)(6) 2014.It was not until (b)(6) 2014 that it was determined it was most likely "severe pacemaker pocket neuralgia".The patient had a pocket revision on (b)(6) 2014 and then follow up on (b)(6) 2014.Md states marked improvement in pain.

Manufacturer Narrative

(b)(4) 2015 - the patient has stated there is still recurrent pocket pain since (b)(6) 2014 and a diagnosis of musculoskeletal pain from lack of use was given.Patient was started on pain medications.This is all of the information at this time.Should additional information be provided, this event will be updated.(b)(6) 2015 - this patient was still having pocket pain, so the physician revised the pocket, again, on (b)(6) 2015.All available information suggests this device is still actively implanted.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.Additional 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.

Manufacturer Narrative

On (b)(6) 2015 - the patient has stated there is still recurrent pocket pain since (b)(6) 2014 and a diagnosis of musculoskeletal pain from lack of use was given.Patient was started on pain medications.This is all of the information at this time.Should additional information be provided, this event will be updated.On (b)(6) 2015 - this patient was still having pocket pain, so the physician revised the pocket, again, on (b)(6) 2015.All available information suggests this device is still actively implanted.On (b)(6) 2015 - previous revision resolved the pain issue, until the patient came for a follow-up on (b)(6) 2015 with complaints of recurrent pocket pain.Device still remains implanted.On (b)(6) 2016 - it was noted the pain was resolved after having some type of minor surgery and shots, not disclosed in the ov note.

• 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: 4332959
• MDR Text Key: 16894757
• Report Number: 1028232-2014-006051
• 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: Nurse
• Type of Report: Initial,Followup,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?: Yes
• Initial Date Manufacturer Received: 04/08/2015
• Initial Date FDA Received: 12/16/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/09/2015; 05/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2013
• 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: 80 YR