MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG CELERITY 2D 85 US; LV LEAD

Model Number	383395
Medical Device Problem Code	High Capture Threshold (3266)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
This lead was capped due to very high lv thresholds causing device battery depletion.
Additional Manufacturer Narrative
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 manufacturing documents of the device as well as on the provided data.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.The available data showed the pacing impedance value of 342 ohms and the pacing threshold 4v @ 1ms on (b)(6) 2019.Between the (b)(6) 2019 the threshold increased by 1v exceeding the safety margin of 0.5v.No trend records of pacing impedance or pacing threshold were available.In spite of the available information, no conclusion can be drawn regarding the root cause of the clinical observation.Should additional information or the device itself become available for analysis, the investigation will be updated.

• Brand Name: CELERITY 2D 85 US
• Common Device Name: LV LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 9452130
• Report Number: 1028232-2019-05471
• Device Sequence Number: 3040514
• Product Code: OJX
• UDI-Device Identifier: 04035479143268
• UDI-Public: 04035479143268
• Combination Product (Y/N): N
• PMA/510(K) Number: P070008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2016
• Device Model Number: 383395
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization