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

Model Number 401183

Device Problems High impedance (1291); Ambient Noise Problem (2877)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

The lead is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.

Event Description

Alert received via hm of lv lead impedance was greater than 3000 ohms.During a device check performed in the hospital there was a noise interruption by patient body movement.Lv lead replacement operation is scheduled.

Manufacturer Narrative

This device was explanted and returned for analysis.Upon receipt, the lead under complaint was found cut 57cm proximal to the lead tip.Only the distal fragment was returned.The proximal fragment including the is4 connector pin was not returned.An explantation aid was found in the lead body.It is reasonable to assume that the lead was cut during the explantation procedure.The performance of the lead fragment was scrutinized, including a visual inspection.The analysis revealed 45cm proximal to the lead tip that the lead body was found squeezed and deformed.In this area all the conductor coils were found fractured, which is assumed to be the root cause of the reported high pacing lead impedance.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.Further damages such as several cuts into the insulation and a damaged distal end, most likely occurred during the explantation procedure.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-85
• Type of Device: LV LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10638041
• MDR Text Key: 210151047
• Report Number: 1028232-2020-04297
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 04035479138448
• UDI-Public: 04035479138448
• Combination Product (y/n): N
• PMA/PMN Number: P070008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 401183
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Date Manufacturer Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1