MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RELIATY; EXTERNAL PSA

Model Number 365530L

Device Problem Pacing Problem (1439)

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

Event Date 02/27/2015

Event Type  malfunction  

Event Description

The representative reports that during a case on a dependent patient the reality stopped pacing and there was intermittent sensing.The reality was connected electrically to power.Normal pacing function was observed when the leads were connected to the pacemaker.

Manufacturer Narrative

Upon receipt, the pacing system analyzer was inspected.Despite the damaged case stands, which were replaced, the device did not show any deviation during analysis.No indication which might have contributed to the clinical observation was revealed.The visual, mechanical and functional analysis revealed no anomalies and no material or manufacturing deviation was found.

• Brand Name: RELIATY
• Type of Device: EXTERNAL PSA
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-12 359; GM D-12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 4601419
• MDR Text Key: 5628022
• Report Number: 1028232-2015-00780
• 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
• Source Type: Invalid Data
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 365530L
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2012
• 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): Hospitalization