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

Model Number 365529

Device Problem Pacing Problem (1439)

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

Event Date 04/04/2016

Event Type  malfunction  

Event Description

Technician claims that external pacemaker stopped pacing when cover was slid down.They would like an analysis on why this happened or to verify that the unit is working normally.Patient was dependent on unit and another was swapped in.

Manufacturer Narrative

Upon receipt, the external pacemaker including the redel adapter was inspected.Apart from signs of usage no deviation was found related to the clinical observation during analysis.Further analysis including an intensive long term investigation of the device pacing and sensing functions under mechanical stress did not reveal any indication of a device malfunction.In particular the use of the protective cover and its possible effects on the stimulation behavior was observed, but no anomaly could be found.In summary, the visual, mechanical and functional analysis revealed no indication of a material or manufacturing problem.

• Brand Name: REOCOR D
• 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: 5624356
• MDR Text Key: 44174595
• Report Number: 1028232-2016-01440
• Device Sequence Number: 1
• Product Code: OVJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 365529
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening