MAUDE Adverse Event Report: MPRI STYLET KIT; STYLET, CATHETER

Model Number 6057-58

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the implant procedure, the pacing lead helix was not smoothly extended and movement of the helix became extremely dull.It was further reported that the insertion of a stylet became difficult.It was also reported that the pacing lead thresholds were not favourable.The pacing lead was removed and replaced.No patient complications have been reported as a result of this event.

• Brand Name: STYLET KIT
• Type of Device: STYLET, CATHETER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10274710
• MDR Text Key: 199501498
• Report Number: 2649622-2020-13508
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00681490140003
• UDI-Public: 00681490140003
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/15/2020

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: 07/10/2022
• Device Model Number: 6057-58
• Device Catalogue Number: 6057-58
• Device Lot Number: VA1SXG3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 07/15/2020
• Date Device Manufactured: 08/24/2018
• 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