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

Model Number	401183
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approximately 7 months, it was reported that the lead was extracted due to an impedance issue.Sensing polarity was switched to unipolar automatically.
Additional Manufacturer Narrative
The lead and the pacemaker were returned for analysis.Prior to the analysis of the lead and the pacemaker, the manufacturing process for these devices was re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.Upon receipt, the pacemaker was interrogated and the memory content was analyzed.The pacemaker detected left ventricular lead failures as a result of measured left ventricular lead impedances out of range.No further anomalies were noted.The header of the device was analyzed.The set screws could be easily screwed in and out, there was no foreign material inside the header bores.All dimensions of the header bores were within the range requested by the standard specifications.Also the spring elements of the pacemaker did not show any deviations.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.Additionally, the impedance measurement functions of the device were extensively tested.Different load resistances were subsequently attached to the pacemaker and the device measurements in bi- and unipolar configuration were proven to be normal and as expected.There was no indication of a device malfunction.Upon receipt the performance of the lead was scrutinized including a visual, mechanical and electrical inspection.Approximately 41cm distal to the is4 connector pin the lead body was found squeezed and deformed.This damage is assumed to be the root cause of the 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.Prior to the analysis of the devices, the quality documents accompanying the manufacturing processes for device and lead were re-investigated.All production steps were performed accordingly, and in particular the final acceptance tests proved the devices functions to be as specified.In conclusion, the device is fully functional.The analysis did not show any deviations from the technical specifications.The analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: SENTUS PROMRI OTW QP L-85
• Common Device Name: LV LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 12619885
• Report Number: 1028232-2021-05610
• Device Sequence Number: 1479289
• Product Code: OJX
• UDI-Device Identifier: 04035479138448
• UDI-Public: 04035479138448
• Combination Product (Y/N): N
• PMA/510(K) Number: P070008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2021

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: 09/30/2022
• Device Model Number: 401183
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown