MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RENAMIC; PROGAMMER

Model Number 365533

Device Problem Pacing Problem (1439)

Patient Problem Cardiac Arrest (1762)

Event Date 02/05/2016

Event Type  malfunction  

Event Description

This programmer was returned with documentation stating "during an upgrade procedure, the analyzer failed to rv pace.When the physician disconnected the lv lead the patient flatlined (patient is pacer dependent) even though rv channel was on and pacing was on at 5.0v@0.4ms (rv threshold was 0.4v@0.4ms).

Manufacturer Narrative

Upon receipt, the programmer and monitoring device including the programming head and the renamic psa module 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 psa pacing and sensing functions under mechanical stress did not reveal any indication of a device malfunction.In particular the rv channel was observed, but no anomaly could be found.The described behavior possibly could have been observed in a configuration where lv sensing was active while the lv lead was disconnected.In that case interferences from electromagnetic fields might have been detected as lv sense signals and depending on the chosen pacing program might have caused the inhibition of the rv channel.So external influences may have led to the observed behavior.It does not represent a device malfunction.The visual, mechanical and functional analysis revealed no indication of a material or manufacturing problem.

• Brand Name: RENAMIC
• Type of Device: PROGAMMER
• 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: 5466528
• MDR Text Key: 39235825
• Report Number: 1028232-2016-00560
• Device Sequence Number: 1
• Product Code: KRG
• 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: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 365533
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2016
• Initial Date FDA Received: 02/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2013
• 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): Hospitalization; Life Threatening