MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG VOLTA 1CR 65 US; ICD LEAD

Model Number	384075
Medical Device Problem Codes	Failure to Capture (1081); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/26/2016
Type of Reportable Event	Malfunction
Event or Problem Description
At 1-week follow-up, rv lead threshold was normal at 0.50v @ 0.50ms.At the 3-month visit, threshold had increased to 4.0v @ 0.50ms.Then, at the 6-month visit on (b)(6) 2016, there was no capture of the rv lead.On (b)(6) 2016, patient underwent rv lead revision due to dislodgement.
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 analysis of the provided rv pacing threshold tests, performed on (b)(6) 2015, confirmed a pacing threshold of 4.0 v with a pulse width of 1.0 ms.In spite of the available information, no conclusion can be drawn regarding the root cause of the observed dislodgement.An analysis of the lead itself would be necessary to determine the root cause.

• Brand Name: VOLTA 1CR 65 US
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10311864
• Report Number: 1028232-2020-03033
• Device Sequence Number: 3217647
• Product Code: NVY
• UDI-Device Identifier: 04035479143374
• UDI-Public: 04035479143374
• Combination Product (Y/N): N
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: 384075
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 11/25/2020
• 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