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

Model Number 401181

Device Problem Ambient Noise Problem (2877)

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

Event Date 12/19/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021 in routine follow up, noises were observed on the rv lead and the lv lead on iemg.Device in recall group.Rv and lv lead will be replaced with the icd due to recall, status is currently unknown.

Manufacturer Narrative

The icd was received for analysis and inspected.Upon receipt the icd was interrogated.The interrogation could be properly performed and revealed the mos1 battery status.All electrical parameters were verified and showed a normal device behavior.Especially, the current consumption and the battery state of discharge were found normal and as expected.There was no indication of a device malfunction.The leads were not returned for analysis.However, available device data, particularly statistical trend data were inspected thoroughly revealing no anomalies.Iegms were not available for analysis.The root cause for the observed noise could not be determined based on all data available.The quality documents accompanying the manufacturing process for the devices were re-investigated.All production steps were performed accordingly.There was no indication of a material or manufacturing problem.

Manufacturer Narrative

The icd and the leads under complaint were returned for analysis.The manufacturing process for the devices was re-investigated, revealing that all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance test proved the devices functions to be as specified.Intica 5 hf-t qp df4 is4 promri: upon receipt, the device was interrogated.The interrogation could be properly performed and revealed the mos1 battery status.All electrical parameters were verified and showed a normal device behavior.Especially, the current consumption and the battery state of discharge were found normal and as expected.There was no indication of a device malfunction.Sentus promri otw qp s-95: upon receipt, the lead under complaint was found cut 14 cm distal to the is4 connector pin.The proximal fragment was received for analysis.The distal fragment was not returned.The returned lead fragment was analyzed.The inspection revealed that the insulation was, apart from the present cut, free of breaches.Further analysis of the returned lead fragment did not reveal any irregularity that might have contributed to the reported clinical observations.Plexa promri s 65: upon receipt, the lead under complaint was found cut 11 cm distal to the df4 connector pin.The proximal fragment was received for analysis.The distal fragment was not returned.The returned lead fragment was analyzed.The inspection revealed that the insulation was, apart from the present cut, free of breaches.Further analysis of the returned lead fragment did not reveal any irregularity that might have contributed to the reported clinical observations.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: SENTUS PROMRI OTW QP S-95
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 13180093
• MDR Text Key: 283421791
• Report Number: 1028232-2022-00065
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 04035479138424
• UDI-Public: 04035479138424
• Combination Product (y/n): N
• PMA/PMN Number: P070008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: 401181
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2022
• Initial Date FDA Received: 01/06/2022
• Supplement Dates Manufacturer Received: 06/17/2022
• Supplement Dates FDA Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1