NA 5019 (UDI 00613994220288)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994220288), received between Aug 9, 2017 and Sep 29, 2022 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE MONTH POST GENERATOR CHANGE, THE PATIENT¿S INCISION BEGAN TO OPEN ON ONE END AND THE DEVICE WAS VISIBLE. THE DEVICE POCKET WAS FOUND TO BE INFECTED AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS THEN EXPLANTED. THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 15508071 ↗
• MalfunctionFeb 3, 2020Break; Break

  IT WAS REPORTED THAT THE LEAD EXHIBITED HIGH IMPEDANCE AND HAD A POSSIBLE FRACTURE. IT WAS ALSO REPORTED THAT THE SPLITTER TOOL HAD A "POSSIBLE CONNECTOR FRACTURE." THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9659989 ↗
• InjurySep 7, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT¿S HIGH VOLTAGE LEAD WAS EXHIBITING HIGH/UNDEFINED SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE. A FRACTURE OF THE HIGH VOLTAGE LEAD WAS SUSPECTED. THE HIGH VOLTAGE LEAD WAS EXPLANTED AND REPLACED. IN ADDITION, THE ADAPTOR WAS ALSO EXPLANTED AND REPLACED, AS IT WAS UNKNOWN IF THE ADAPTOR CONTRIBUTED TO THE IMPEDANCE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7855282 ↗
• MalfunctionFeb 8, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE PATIENT REQUIRED PLACEMENT OF AN ADDITIONAL ARRAY DUE TO HIGH DEFIBRILLATION TESTING WHERE THREE SHOCKS WERE NEEDED TO CONVERT THE RHYTHM. THE ARRAY WAS CONNECTED VIA THE ADAPTOR TO THE DEVICE. DEFIBRILLATION TESTING WAS PERFORMED WITH SUCCESS AND ALL THE MEASUREMENTS WERE FOUND TO BE WITHIN NORMAL RANGE. APPROXIMATELY TWO OR THREE DAYS LATER, THE RIGHT VENTRICULAR LEAD DISPLAYED HIGH THRESHOLDS, THERE WAS A JUMP IN IMPEDANCE AND THE IMPEDANCE WAS HIGH. TESTING REVEALED THE HIGH VALUES WERE REPEATEDLY CONFIRMED. FOLLOWING, THE PATIENT WAS ADMITTED TO THE OPERATING ROOM FOR A LEAD REVISION; HOWEVER, AT THAT TIME THE MEASUREMENTS WERE FOUND TO BE NORMAL. IT WAS ALSO REPORTED THERE WAS A POSSIBILITY THERE WAS AN INTERACTION WITH THE ADAPTOR. THE CARDIOLOGIST AND SURGEON DECIDED TO FOLLOW THE PATIENT AND THE LEAD REVISION WAS NOT PERFORMED. THE DEVICE AND LEAD REMAIN IN USE AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7254993 ↗
• InjuryAug 9, 2017Impedance Problem; Impedance Problem

  IT WAS REPORTED THE LEAD DISPLAYED A SUDDEN SHOCK IMPEDANCE SPIKE. ADDITIONALLY, THE LEAD WAS IMPLANTED PAST THE USE BY DATE. THE ADAPTER WAS REMOVED AND REPLACED. FOLLOWING, THE LEAD "STILL SHOWS ERRONEOUS IMPEDANCE." THE LEAD REMAINS IN USE AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6783621 ↗