MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SENTUS PROMRI OTW QP S-85; LEAD

Model Number	401180
Medical Device Problem Codes	Failure to Capture (1081); Ambient Noise Problem (2877); Impedance Problem (2950)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
This lead was explanted due to out of range impedance, noise, and loss of capture in all configurations.After extraction, stylet could not be inserted further than approximately 2.5 centimeters.
Additional Manufacturer Narrative
Upon receipt, the lead under complaint was subjected to an extensive analysis.The performance of the lead was scrutinized, including a visual inspection.Ligature marks were detected 47 cm distal the is4 connector pin.48 cm distal to the is4 connector pin all conductor coils were found broken and the insulation was found abraded.This damage is assumed to be the root cause for the observed out of range impedance.Based on the characteristics, as well as the location of the damage, it is reasonable to assume that the lead was bend immediately distal to the fixation sleeve, which lead to excessive mechanical stress in the implanted state.Further analysis revealed a damaged kink protection tube 2.5 cm distal the is4 connector and thus blocking the insertion of a stylet.A forced insertion or removal of the guidewire or the is4/df4 adapter might have caused the damage to the kink protection tube.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.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: SENTUS PROMRI OTW QP S-85
• Common Device Name: LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 9714823
• Report Number: 1028232-2020-00740
• Device Sequence Number: 2500656
• Product Code: OJX
• UDI-Device Identifier: 04035479138417
• UDI-Public: 04035479138417
• Combination Product (Y/N): N
• PMA/510(K) Number: P070008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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: 04/30/2019
• Device Model Number: 401180
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 08/27/2020
• 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