MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SENTUS PROMRI OTW BP L-95

Model Number 398678

Device Problems Fracture (1260); High impedance (1291); Pacing Problem (1439)

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

Event Date 02/03/2021

Event Type  malfunction  

Event Description

After an implantation period of approx.78 months, a lead fracture was observed.The impedance had increased and stimulation was unsuccessful.The lead was explanted.

Manufacturer Narrative

Upon receipt, the lead under complaint was found capped 52cm proximal to the lead tip.The distal fragment was received for analysis.The proximal fragment was not returned.An extraction aid was found in the lead body.The performance of the lead fragment was scrutinized, including a visual inspection.The analysis revealed cuts into the insulation 30cm proximal to the lead tip and a deformed lead body from 48cm to 50cm proximal to the lead tip, which most likely resulted from the extraction procedure.However, a thorough analysis of the returned lead fragment did not show any deviations which might have led to the reported complaint description.The manufacturing processes for both leads (sn:48925607/48925685) were 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 BP L-95
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 11475075
• MDR Text Key: 241722627
• Report Number: 1028232-2021-01210
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• 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: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: 398678
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Date Manufacturer Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization