MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG EVIA HF-T; CRT-P

Model Number 377208

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

Patient Problem Burning Sensation (2146)

Event Date 07/15/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

We were notified that this patient experienced a burning sensation at the device implant site on (b)(6) 2015.Patient denied redness, warmth, swelling, drainage, fever, and chills.Patient called clinic (b)(6) 2015 to report burning sensation again.The pain radiated into the left breast, neck, and left shoulder to elbow.Patient denies sob, lh, palpitations, nausea of diaphoresis.The patient said the pain intensifies with stress or exertion.Patient presented to the hospital on (b)(6) 2015.Patient complained of overwhelming fatigue and exhaustion as well as heat sensation in her chest, back, and shoulder.Physician ran labs to check for acs.The only abnormal lab was an elevated glucose.The patient refused a stress echo and any further testing, and was discharged home.The patient had follow up with her cardiologist on (b)(6) 2015 and no mention was made of her device site or the burning sensation that she had been experiencing.The system remains implanted.Should additional information become available, this file will be updated.

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: EVIA HF-T
• Type of Device: CRT-P
• 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: 6886188
• MDR Text Key: 87160130
• Report Number: 1028232-2017-03422
• Device Sequence Number: 1
• Product Code: NKE
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 377208
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2014
• 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: 59 YR