MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG VOLTA 2CR 60/16 US; ICD LEAD

Model Number	384105
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Ambient Noise Problem (2877)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	06/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn at this time.The investigation will be re-opened should additional data become available.
Event or Problem Description
It was reported this rv lead was explanted and replaced due to inappropriate shocks and noise.
Additional Manufacturer Narrative
On 11/28/18 - updated analysis received.Upon receipt, the lead under complaint was found cut approx.15 cm distal to the is-1 connector pin.Only the proximal fragment was received for analysis.The distal fragment, including the shock coils and the lead tip, was missing.The returned lead fragment was visually and electrically analysed.The visual inspection revealed that the insulation was, apart from the present cut, free of breaches.During the electrical analysis, the dc resistances of the received conductor fragment were measured.No peculiarities were found.Further analysis of the returned lead fragment did not reveal any irregularity that might have contributed to the reported clinical observation.The manufacturing process for this lead was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: VOLTA 2CR 60/16 US
• Common Device Name: ICD LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• MDR Report Key: 7651176
• Report Number: 1028232-2018-02228
• Device Sequence Number: 1871669
• Product Code: NVY
• UDI-Device Identifier: 04035479143398
• UDI-Public: (01)04035479143398
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P980023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2018

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 Model Number: 384105
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 01/18/2019
• 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