SJM™ 405108Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05414734204101), received between Jan 4, 2019 and Apr 28, 2023 — classified as 1 death, 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  FOLLOW UP REPORT NEEDED TO ADDRESS ANALYSIS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16836758 ↗
• MalfunctionApr 15, 2022Difficult to Insert; Difficult to Insert

  DURING ICD IMPLANT PROCEDURE, AN AXILLARY VEIN WAS PUNCTURED AND AT THE TIME OF PASSING THE GUIDEWIRE IT DID NOT PASS THROUGH THE NEEDLE AND WAS STUCK. ANOTHER ANGIOGRAPHIC NEEDLE AND ANOTHER SHORT GUIDEWIRE WERE USED, THE SAME PEEL AWAY WAS USED. A NEW PUNCTURE OF THE LEFT SUBCLAVIAN VEIN IS REQUIRED DUE TO INADEQUATE FUNCTIONING OF THE NEEDLE AND THE GUIDEWIRE, WITH THE GUIDEWIRE GETTING STUCK IN THE LUMEN OF THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14116741 ↗
• InjuryAug 20, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  DURING A DUAL IMPLANT PACEMAKER PROCEDURE, THE INTRODUCER WAS NOT ABLE TO BE SPLIT SUCCESSFULLY. A SCISSORS WAS USED TO SPLIT THE INTRODUCER AND WHILE DOING SO, THE LEAD DISPLACED. AS THE PATIENT WAS PACING-DEPENDENT, THE PATIENT WENT INTO ASYSTOLE FOR TEN SECONDS. AT THAT POINT, THE STEALTH WAS CUT AWAY AND AS THE LEAD REMAINED IN THE ACCESS SITE, A STYLET WAS USED TO REPOSITION THE LEAD. AFTER SUCH, THE HEART WAS ABLE TO BE PACED AND THE PATIENT WAS NOTED TO BE STABLE WITH NO ADVERSE CONSEQUENCES. THE FORCE USED TO SPLIT THE SHEATH AND THEN HAVING TO USE A SCISSORS BOTH CONTRIBUTED TO THE DISPLACEMENT OF THE LEAD.

  Patient problems: Arrhythmia

  MAUDE report 12349090 ↗
• DeathJan 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 2017865-2018-19534, 2017865-2018-19537, 2017865-2018-19539. FOLLOWING A PACEMAKER IMPLANT ON (B)(6) 2018, THE PATIENT EXPIRED THE FOLLOWING DAY. THE CAUSE OF DEATH IS UNKNOWN AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Death

  MAUDE report 8218446 ↗