MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG REOCOR D; EXTERNAL PACEMAKER

Model Number	365529
Medical Device Problem Codes	Device Sensing Problem (2917); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this external device sensed incorrectly and paced inappropriately causing a ventricular arrhythmia in a postoperative patient.The device was put aside and returned for analysis.
Additional Manufacturer Narrative
Upon receipt, the external pacemaker was subjected to an extensive analysis.Within this analysis the device was visually, mechanically and functionally inspected.The visual inspection already showed that the device had severe external damage, which indicates a fall.During the functional analysis the clinical observation could not be confirmed.The device proved to be fully functional.The electrode impedance measurement and the antibradycardia therapy capability were tested.The measurement results were within the specifications.Due to the severe external damage, safe operation of the device cannot be guaranteed.A repair is therefore not possible.The visual, mechanical and functional analysis revealed no indication of a material or manufacturing problem.

• Brand Name: REOCOR D
• Common Device Name: EXTERNAL PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 13342707
• Report Number: 1028232-2022-00411
• Device Sequence Number: 5303087
• Product Code: OVJ
• UDI-Device Identifier: 04035479110055
• UDI-Public: 04035479110055
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 365529
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2020
• 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
• Patient Sex: Unknown