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

Model Number 365528

Device Problems Pacing Problem (1439); Device Sensing Problem (2917)

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

Event Date 06/24/2017

Event Type  malfunction  

Event Description

Ous mdr - it was reported that an alert was notet by central monitor at the hospital.When a staff arrived at the patient room, flashing led of both sensing and pacing of the reocor was observed.As it was assumed that pacing might have interrupted, the reocor was exchanged immediately.Since the patient had self-pulse (30 bpm) , the event did not cause any adverse events.

Manufacturer Narrative

Upon receipt, the external pacemaker was inspected.No deviation was found related to the clinical observation during analysis.No indication which might have contributed to the clinical observation was revealed.The visual, mechanical and functional analysis revealed no indication of a material or manufacturing problem.

• 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: 6796354
• MDR Text Key: 82762420
• Report Number: 1028232-2017-02813
• 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
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• 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: 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2014
• 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): Required Intervention