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

Model Number	401182
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Approximately 45 months after implantation, home monitoring system reported impedance greater than 3000 ohms on lv lead.Lead was explanted and replaced.No adverse patient events were reported.
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 the ligature marks approximately 27cm distal to the is4 connector pin.Abrasion marks were found along the lead body.Further inspection showed a deformed insulation approximately 29cm distal to the is4 connector pin.In that section, the conductor coil was found fractured.This broken contact was confirmed during the electrical analysis.Based on the characteristics as well as the location of the damage, it is reasonable to assume that the lead had been subject to excessive mechanical forces as the result of clavicular first rib entrapment.Furthermore, cuts in the insulation were observed which occurred most likely during the explantation procedure.Blood penetrated the lead.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: 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: 8633061
• Report Number: 1028232-2019-02043
• Device Sequence Number: 13907351
• 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: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2019

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: 09/30/2016
• Device Model Number: 401182
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 08/12/2019
• 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