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

Model Number 365529

Device Problem Pacing Problem (1439)

Patient Problem Ventricular Tachycardia (2132)

Event Date 09/24/2015

Event Type  malfunction  

Event Description

Ous mdr - the following is what was reported:at 12:30 the monitor of my patient has started alarming for ventricular tachycardia.The pacing box the patient was connected to started firing at 120 - 140 bpm.This pacing box was set as a backup with the parameters: mode:ddd, rate:60, av delay:200, atrial sensitivity:0.3, atrial output: 6, ventricular sensitivity: 6, ventricular output: 10.Immediately contacted with a senior nurse who changed the parameters of the pacing box and reduced the rate until 40; however, even after these changes, the pacing box was still firing at the same rate.The patient had an underlying rhythm of sinus rhythm with bundle branch block of 80-95 bpm.The device has been returned for analysis.

Manufacturer Narrative

This report was opened in error.The manufacturer determined that this event was not reportable.Closing report.

Event Description

Ous mdr - the following is what was reported: at 12:30 the monitor of my patient has started alarming for ventricular tachycardia.The pacing box the patient was connected to started firing at 120 - 140 bpm.This pacing box was set as a backup with the parameters: mode:ddd, rate:60, av delay:200, atrial sensitivity:0.3, atrial output: 6, ventricular sensitivity: 6, ventricular output: 10.Immediately contacted with a senior nurse who changed the parameters of the pacing box and reduced the rate until 40; however, even after these changes, the pacing box was still firing at the same rate.The patient had an underlying rhythm of sinus rhythm with bundle branch block of 80-95 bpm.The device has been returned for analysis.

• Brand Name: REOCOR D
• Type of Device: 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: 5217014
• MDR Text Key: 30983485
• Report Number: 1028232-2015-04044
• Device Sequence Number: 1
• Product Code: OVJ
• Combination Product (y/n): N
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2015
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2019
• 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): Hospitalization