MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG BIOMONITOR 2-AF; IMPLANTABLE CARDIAC MONITOR

Model Number	398493
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Implant Pain (4561)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Keystone dental inc.Provides labeling with all implants.Failure to osseointegrate and loss of osseointegration (implant mobility) is identified as an adverse reaction and identified in the list of warnings in all endosseous dental implant labeling.The specific cause for a particular complaint is often not readily identified as there are various factors that contribute to the risk of implant failure.These include patient factors such as prior oral infection, poor bone quality or quantity, systemic conditions such as diabetes and uncontrolled hypertension.Technique factors such as overheating of the implant site may cause necrosis of the bone, preventing growth (pelayo et al., 2008; turkyilmaz & al., 2008).Patient habits such as tobacco use (heitz-mayfield & huynh-ba, 2009), alcohol or drug abuse, poor oral hygiene, and bruxism (salvi & braegger, 2009) may also lead to implant failure.In addition, improper surgical technique can lead to implant failure and/or loss of supporting bone (salvi & braegger, 2009).
Event or Problem Description
Device was explanted due to migration and pain.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
Migration was observed following the implantation of this biotronik device.Therefore, the device as received was visually inspected.The visual inspection revealed no external anomalies.The quality documents associated with the manufacture of this particular device were re-investigated.There was no sign of any inconsistency during production and final acceptance test.In conclusion there was no indication of a material or manufacturing problem.

• Brand Name: BIOMONITOR 2-AF
• Common Device Name: IMPLANTABLE CARDIAC MONITOR
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 17162697
• Report Number: 1028232-2023-03093
• Device Sequence Number: 5563796
• Product Code: MXD
• UDI-Device Identifier: 04035479135522
• UDI-Public: (01)04035479135522(17)171231
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: 398493
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female