MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG TILDA T 60 US; PACING LEAD

Model Number	382878
Medical Device Problem Codes	Failure to Capture (1081); High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported this lead was replaced due to high impedance and loss of capture.The lead was capped.
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 quality documents associated with the manufacture of this particular 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 provided data did not include any impedance trend curve.However the impedance test performed on the (b)(6) 2018 showed a value of greater than 3000 ohms as reported in the complaint text.In spite of the available information, no conclusion can be drawn regarding the root cause of the clinical observation.An analysis of the lead would be necessary for a root cause investigation.Should additional information or the device itself become available for analysis, the investigation will be updated.

• Brand Name: TILDA T 60 US
• Common Device Name: PACING LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• MDR Report Key: 7690630
• Report Number: 1028232-2018-02385
• Device Sequence Number: 13683126
• Product Code: NVN
• UDI-Device Identifier: 04035479143350
• UDI-Public: (01)04035479143350
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P950037
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2018

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 Model Number: 382878
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 10/02/2018
• 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