MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ELUNA 8 DR-T PROMRI; PACEMAKER

Model Number 394969

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Gangrene (1873)

Event Date 10/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

This system was explanted due to gangrene.A boston scientific system was implanted.Should additional information be received, this file will be updated.

Manufacturer Narrative

The device was received and analyzed.The memory content of the pacemaker was inspected, showing a normal device function while implanted and in service.The pacemaker was subjected to an electrical analysis.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.In conclusion, the device proved to be fully functional.The analysis of the memory content showed a normal device behavior while the device was implanted and in service.There was no indication of a device malfunction.Biotronik monitors the post-market performance of its products closely in order to identify any trends that may reveal over time a potential manufacturing or design issue.The historic performance of the product involved in the current case does not at this point reveal any such trend.For this reason we encourage close dialogue between clinicians and our product experts in order to explore all options to minimize any such occurrences in future.

• Brand Name: ELUNA 8 DR-T PROMRI
• 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: 6214098
• MDR Text Key: 63569235
• Report Number: 1028232-2016-05174
• Device Sequence Number: 1
• Product Code: NVZ
• 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: 12/13/2016

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?: No
• Device Operator: Health Professional
• Device Model Number: 394969
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• 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 Outcome(s): Hospitalization
• Patient Age: 66 YR