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

Model Number 407157

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

Patient Problems Pocket Erosion (2013); Twiddlers Syndrome (2114)

Event Date 05/27/2020

Event Type  Injury  

Event Description

Patient reportedly picked at incision, eventually causing device erosion.System was explanted.Should additional information be received, this file will be updated.

Manufacturer Narrative

An erosion was observed following the implantation of this biotronik device.The sterilization process was investigated.The validated process assures that all sterilization parameters, such as gas concentration, temperature, humidity, etc., are within its specified ranges for each distributed device.Additionally an analysis of validated microbiological indicators is performed after every sterilization procedure as evidence of successful completion of the sterilization process.Review of the biotronik complaint database did not reveal any changes regarding the trend for this type of incident.In conclusion, the erosion was not device related.

• Brand Name: EDORA 8 SR-T
• Type of Device: PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10106931
• MDR Text Key: 193278816
• Report Number: 1028232-2020-02226
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 04035479147761
• UDI-Public: 04035479147761
• 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
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

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 Expiration Date: 12/31/2020
• Device Model Number: 407157
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/01/2020
• Supplement Dates Manufacturer Received: 07/14/2020
• Supplement Dates FDA Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 78 YR