MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SENTUS PROMRI OTW QP L-75; LV LEAD

Model Number	401182
Medical Device Problem Codes	Failure to Capture (1081); High impedance (1291); Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Lv lead did not capture, impedance was higher than 3000 ohms and noise was present on iegm channel.The patient was hospitalized and the lv lead replaced.Both the lv lead and device have been substituted.
Additional Manufacturer Narrative
Upon receipt, the lead under complaint was subjected to an extensive analysis.The performance of the device was scrutinized, including a visual and electrical inspection.The visual inspection revealed 32 cm distal to the is4 connector pin that the lead body was found squeezed and deformed.In this area the conductor coils leading to the ring electrodes and to the lead tip were found fractured, which is assumed to be the root cause of the reported clinical observation.Based on the characteristics, as well as the location of the damage, it is reasonable to assume that the lead was subject to excessive mechanical forces as the result of clavicular first rib entrapment.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 L-75
• Common Device Name: LV LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10878085
• Report Number: 1028232-2020-05073
• Device Sequence Number: 11844567
• Product Code: OJX
• UDI-Device Identifier: 04035479138431
• UDI-Public: 04035479138431
• Combination Product (Y/N): N
• PMA/510(K) Number: P070008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 11/12/2020

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: 02/28/2019
• Device Model Number: 401182
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 03/10/2021
• 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