MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ETRINSA 8 HF-T; PACEMAKER

Model Number 394919

Device Problems Pacemaker Found in Back-Up Mode (1440); Device Displays Incorrect Message (2591)

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

Event Date 03/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

This device was interrogated and found in backup mode.When reinitializing the device, a battery error appeared.This device remains implanted.

Manufacturer Narrative

We received your event description for the above mentioned device.As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The analysis is thus based on the inspection of the quality documents associated with the manufacture of this particular device as well as the data returned for evaluation.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance test proved the device functions to be as specified.The data returned for analysis were inspected.The inspection revealed that the device switched into the safety backup mode on march 14, 2017 as a result of the detection of invalid memory content.The device was reinitialized on march 30, 2017.By design, the pacemaker performs self-checks and is equipped with the ability to detect and repair invalid memory content.However, in the case of multiple invalid memory areas, the device cannot correct the memory content and switches into the safety backup mode to assure the patients safety.While in this safety program, the pacemaker is capable to deliver anti-bradycardia therapies.Upon interrogation a device status error message appears to notify the user.The activation of the safety backup mode does not indicate a material or manufacturing problem.The reported warning message as mentioned in the complaint description resulted from a temporary elevated current consumption which may arise due to the activation of the safety back mode.However, to confirm a flawless device behavior after the reinitialization a further pacemaker dump would be essential.In summary, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.The available data revealed that the clinical observation resulted from invalid memory content.The root cause for the invalid memory content was not determinable.External influences such as strong electromagnetic fields could be taken into consideration.However, to confirm a flawless device behavior after the reset procedure a further pacemaker dump would be essential.

• Brand Name: ETRINSA 8 HF-T
• Type of Device: 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: 6501340
• MDR Text Key: 73101390
• Report Number: 1028232-2017-01148
• Device Sequence Number: 1
• Product Code: NKE
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 394919
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2017
• Initial Date FDA Received: 04/18/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2016
• 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 Age: 88 YR