NA 672625Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00721902066801), received between Apr 6, 2017 and Apr 1, 2024 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT¿S DEVICE WAS MOVED TO THE PATIENT¿S ABDOMEN IN (B)(6) 2023 DUE TO RADIATION TREATMENTS AND AN EXTENDER WAS USED FOR THE RIGHT VENTRICULAR (RV) LEAD. NOW THE LEAD IS NOW EXHIBITING HIGH TIP-TO-COIL PACING IMPEDANCES. THE PHYSICIAN IS SUSPECTING THAT THE ADAPTOR IS THE ROOT CAUSE OF THE IMPEDANCE ISSUES.  THE DEVICE IS NOW BEING RETURNED TO THE PECTORAL REGION AND THE ADAPTOR WAS REMOVED. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19013343 ↗
• MalfunctionDec 19, 2022Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT WHEN THE ADAPTOR KIT WAS ATTEMPTED TO BE OPENED IN ORDER TO ACCESS A WRENCH TOOL FOR USE AT AN IMPLANT IT WAS NOTED THAT THE WRENCH WAS GLUED TO THE TOP OF THE STERILE PACKAGING, CAUSING THE ADAPTOR TO "FLING OUT" OF THE PACKAGING WHEN THE KIT WAS OPENED, CONTAMINATING THE STERILE FIELD. THIS HAPPENED TWO TIMES WITH TWO ADAPTOR KITS. THE TOOLS WERE NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16006839 ↗
• MalfunctionDec 19, 2022Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT WHEN THE ADAPTOR KIT WAS ATTEMPTED TO BE OPENED IN ORDER TO ACCESS A WRENCH TOOL FOR USE AT AN IMPLANT IT WAS NOTED THAT THE WRENCH WAS GLUED TO THE TOP OF THE STERILE PACKAGING, CAUSING THE ADAPTOR TO "FLING OUT" OF THE PACKAGING WHEN THE KIT WAS OPENED, CONTAMINATING THE STERILE FIELD. THIS HAPPENED TWO TIMES WITH TWO ADAPTOR KITS. THE TOOLS WERE NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16006778 ↗
• MalfunctionMay 10, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE HIGH VOLTAGE LEAD ADAPTER WAS ATTEMPTED TO BE IMPLANTED BUT NOT USED. THERE WAS A PRODUCT PERFORMANCE ISSUE WITH THE LEAD ADAPTER. THE LEAD ADAPTER WAS REMOVED FROM IMPLANT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14350497 ↗
• InjuryAug 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO INFECTION OF ENDOCARDITIS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 8923575 ↗
• MalfunctionNov 13, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD TRIGGERED AN ALERT FOR HIGH/UNDEFINED SUPERIOR VENA CAVA (SVC) DE FIBRILLATION COIL IMPEDANCE. IT WAS FURTHER DISCOVERED THAT THE RV DEFIBRILLATION COIL IMPEDANCE DISPLAYED HIGH/UNDEFINED IMPEDANCE AND THERE WAS A SMALL AMOUNT OF NOISY ELECTROGRAMS (EGM) INVOLVING THE RV COIL. ADDITIONALLY, THE RV TIP-TO-RV COIL LEAD IMPEDANCE HAD TRIGGERED A WARNING FOR HIGH/UNDEFINED IMPEDANCE, BUT THE LEAD IS CURRENTLY PROGRAMMED TO A BIPOLAR CONFIGURATION. A LEAD FRACTURE IS SUSPECTED. IT WAS NOTED THAT THE PATIENT HAS LEAD EXTENDERS CONNECTED TO BOTH THE SVC COIL AND RV COIL CONNECTIONS AND IT IS UNCLEAR IF THE SUSPECTED FRACTURE IS ON THE LEAD OR THE EXTENDERS. FOLLOW UP WAS CONDUCTED AND IT HAS BEEN VERIFIED THAT NO REPROGRAMMING NOR INTERVENTION HAS BEEN COMPLETED AT THIS TIME. THE LEAD AND EXTENDERS ALL REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8066816 ↗
• MalfunctionNov 13, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD TRIGGERED AN ALERT FOR HIGH/UNDEFINED SUPERIOR VENA CAVA (SVC) DE FIBRILLATION COIL IMPEDANCE. IT WAS FURTHER DISCOVERED THAT THE RV DEFIBRILLATION COIL IMPEDANCE DISPLAYED HIGH/UNDEFINED IMPEDANCE AND THERE WAS A SMALL AMOUNT OF NOISY ELECTROGRAMS (EGM) INVOLVING THE RV COIL. ADDITIONALLY, THE RV TIP-TO-RV COIL LEAD IMPEDANCE HAD TRIGGERED A WARNING FOR HIGH/UNDEFINED IMPEDANCE, BUT THE LEAD IS CURRENTLY PROGRAMMED TO A BIPOLAR CONFIGURATION. A LEAD FRACTURE IS SUSPECTED. IT WAS NOTED THAT THE PATIENT HAS LEAD EXTENDERS CONNECTED TO BOTH THE SVC COIL AND RV COIL CONNECTIONS AND IT IS UNCLEAR IF THE SUSPECTED FRACTURE IS ON THE LEAD OR THE EXTENDERS. FOLLOW UP WAS CONDUCTED AND IT HAS BEEN VERIFIED THAT NO REPROGRAMMING NOR INTERVENTION HAS BEEN COMPLETED AT THIS TIME. THE LEAD AND EXTENDERS ALL REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8066808 ↗
• MalfunctionApr 6, 2017High impedance; High impedance

  IT WAS REPORTED THAT AN ADAPTOR WAS ATTEMPTED BUT NOT USED DURING IMPLANT. THE PHYSICIAN NOTED THAT THE PATIENT HAD A LEFT SIDE SYSTEM BEING MOVED TO THEIR ABDOMEN. THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD COIL IMPEDANCE WAS HIGH THROUGH THE ADAPTOR. THE LEAD WAS TESTED UPON REPLACEMENT OF THE ADAPTOR AND THE IMPEDANCE LEVELS WERE NORMAL. THE ADAPTOR 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 6468626 ↗