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

Model Number 365528

Device Problem Pacing Problem (1439)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Ous mdr - it was reported that the pulse rate output of the device was too high in comparison to the programmed rate.The device was returned to biotronik.No deterioration of the patient's state of health was reported.The event date was not provided.

Manufacturer Narrative

Please note "usage of device" should be reuse.The returned external pacemaker was thoroughly analyzed.It was principally capable to pace and sense.However, it was found during the analysis that the external damages to the operating elements did not allow for a proper operation.Damage and soiling was found.The housing is cracked several times and fractured, and all setting wheels are hard to turn because of the dirt.The visual and mechanical analysis, as well as the function check, did not show any indications of a material defect or manufacturing error.The device was damaged by external impacts.

• Brand Name: REOCOR S
• Type of Device: EXTERNAL 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: 6036469
• MDR Text Key: 57720386
• Report Number: 1028232-2016-03744
• Device Sequence Number: 1
• Product Code: OVJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P950037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 365528
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other