SQ-RX® PULSE GENERATOR 1010 (UDI 00802526521300)Recalls & reported problems

Summary

The FDA's MAUDE database contains 262 adverse event reports that list this exact device (DI 00802526521300), received between Feb 20, 2014 and Aug 19, 2026 — classified as 3 deaths, 143 injuries, 116 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (60 reports).

11 other recalls cover devices cleared under the same FDA submission (P110042); they may or may not involve this specific model.

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 25 most recent of 262 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2026Battery Problem

  It was reported that the device battery had reached end of life back in 2022. The device had been implanted greater than eight years. It was decided to leave the pulse generator implanted. Recently, the patient wanted the system explanted. The entire system was explanted successfully. The condition of the patient had improved so no replacement was done. There were no additional adverse patient effects.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50324073 ↗
• MalfunctionMar 26, 2024Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) HAS BEEN BEEPING FOR OVER ONE YEAR. THE BATTERY IS AT END-OF-LIFE AFTER OVER NINE YEARS OF IMPLANT TIME. TECHNICAL SERVICES DISCUSSED THE BEEPING WITH THE NURSE. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS. THE SYSTEM REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977528 ↗
• MalfunctionMar 14, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING THE NORMAL CHANGE OUT PROCEDURE THE PHYSICIAN EXPERIENCED DIFFICULTY LOOSENING THE SETSCREW ON THE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WITH TWO DIFFERENT TORQUE WRENCHES. TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED TROUBLESHOOTING TECHNIQUES. ULTIMATELY THE SETSCREW WAS ABLE TO BE LOOSENED AND THE ELECTRODE REMOVED. THE ELECTRODE WAS ABLE TO BE IMPLANTED WITH THE NEW S-ICD. NO ADVERSE EFFECTS WERE REPORTED. THE S-ICD WAS EXPLANTED AS PLANNED AND RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16540756 ↗
• MalfunctionMar 14, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A NORMAL DEVICE CHANGE OUT PROCEDURE THE SETSCREW ON THE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS UNABLE TO BE LOOSENED USING A NON-TORQUING WRENCH. TECHNICAL SERVICES (TS) WAS CONSULTED MID CASE, HOWEVER BEFORE ANY TROUBLESHOOTING OCCURRED THE PHYSICIAN WAS ABLE TO LOOSEN THE SETSCREW. THE S-ICD WAS EXPLANTED AS PLANNED. IT WAS NOTED THAT THE S-ICD WAS NOT EXPECTED TO BE RETURNED FOR ANALYSIS AS THE EXPLANTING HOSPITAL KEPT POSSESSION OF DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16539819 ↗
• MalfunctionMar 14, 2023Difficult to Remove; Human-Device Interface Problem; Difficult to Remove; Human-Device Interface Problem

  IT WAS REPORTED THAT THERE WAS DIFFICULTY TO LOOSEN THE SET SCREW TO REPLACE THE DEVICE. TECHNICAL SERVICES DISCUSSED TROUBLESHOOTING. THE PRODUCT WAS SUCCESSFULLY EXPLANT. THERE WERE NO ADVERSE EVENTS.

  Patient problems: Insufficient Information

  MAUDE report 16539404 ↗
• MalfunctionMar 9, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT THIS PATIENT WAS PRESENTED BACK TO THE ELECTROPHYSIOLOGY (EP) LABORATORY FOR A SCHEDULED REPLACEMENT OF THIS CHRONIC SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) DUE TO NORMAL BATTERY DEPLETION. THE PHYSICIAN EXPERIENCED SOME DIFFICULTIES WITH RETRACTION OF THE SET SCREW. EVENTUALLY, THE SET SCREW WAS RETRACTED AND THE TERMINAL PIN OF THE CHRONIC ELECTRODE WAS SUCCESSFUL REMOVED FROM THE DEVICE'S HEADER PORT. THE S-ICD WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16515396 ↗
• InjuryMar 9, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM UNDERWENT A REVISION PROCEDURE DUE TO A DISLODGED ELECTRODE WHICH WAS IDENTIFIED AT A ROUTINE FOLLOW-UP FROM A CHEST X-RAY. THE X-RAY WAS TAKEN DUE TO THE PATIENT BEING HOSPITALIZED RECENTLY FOR RESPIRATORY REASONS. DURING THE ELECTRODE REVISION PROCEDURE, WHEN THE PHYSICIAN RECONNECTED THE ELECTRODE TO THE DEVICE, THE SETSCREW WAS STUCK IN THE UP POSITION AND WOULD NOT TIGHTEN DOWN ON THE ELECTRODE. THE DEVICE WAS EXPLANTED AND RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea

  MAUDE report 16513362 ↗
• MalfunctionMar 9, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING ROUTINE REPLACEMENT OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD), DIFFICULTY WAS ENCOUNTERED WITH LOOSENING THE SET SCREW TO REMOVE THE ELECTRODE FROM THE DEVICE HEADER. DURING ATTEMPTS TO LOOSEN THE SET SCREW, THE TORQUE WRENCH BECAME BROKEN AND A PORTION WAS STUCK IN THE SET SCREW LOCATION. A BONE CUTTER WAS USED AND THE DEVICE HEADER WAS CUT. THE ASSOCIATED ELECTRODE WAS SUCCESSFULLY REMOVED FROM THE DEVICE HEADER. THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 16513262 ↗
• MalfunctionMar 9, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING ROUTINE REPLACEMENT OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD), DIFFICULTY WAS ENCOUNTERED WITH LOOSENING THE SET SCREW TO REMOVE THE ELECTRODE FROM THE DEVICE HEADER. TROUBLESHOOTING WAS PERFORMED AND THE SET SCREW WAS SUCCESSFULLY LOOSENED, AND THE ELECTRODE WAS REMOVED. THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 16513140 ↗
• MalfunctionMar 9, 2023Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING A ROUTINE DEVICE REPLACEMENT PROCEDURE, THE SETSCREW WAS UNABLE TO BE LOOSENED TO REMOVE THE ELECTRODE FROM THE HEADER OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD). TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS. THE SETSCREW WAS UNABLE TO BE LOOSENED FOLLOWING TROUBLESHOOTING. THE DEVICE HEADER WAS CUT, HOWEVER, THE ELECTRODE WAS DIFFICULT TO PUSH OUT OF THE HEADER. MINERAL OIL WAS USED AND THE ELECTRODE WAS SUCCESSFULLY REMOVED. THIS DEVICE WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16513040 ↗
• MalfunctionMar 9, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE EJECTION FRACTION OF THIS PATIENT IMPROVED SIGNIFICATIVELY. AS RESULT, THE PATIENT ELECTED TO REMOVE THE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM. HOWEVER, DURING THE EXPLANT PROCEDURE THIS S-ICD SETSCREW WAS NOT RETRACTING. THE TREATING PHYSICIAN ATTRIBUTED THE DIFFICULTIES TO THE WRENCH AND DECIDED TO CAP THE LEAD TO REMOVE THE DEVICE. THE DEVICE WAS RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16512611 ↗
• MalfunctionMar 8, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING THE CHANGEOUT PROCEDURE OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) THE SETSCREW WAS NOT RETRACTING. THE DEVICE WAS SUCCESSFULLY EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16504608 ↗
• InjuryMar 2, 2023Interrogation Problem; Interrogation Problem

  IT WAS REPORTED THE DEVICE COULD NOT BE INTERROGATED. TECHNICAL SERVICES HAD THE CALLER SELECT "SCAN FOR DEVICE" ON THE PROGRAMMER, AND THE INTERROGATION WAS SUCCESSFUL. THE DEVICE WAS THEN EXPLANTED AND REPLACED FOR NORMAL BATTERY DEPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16467089 ↗
• MalfunctionFeb 28, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING THIS S-ICD EXPLANT DUE TO A NORMAL BATTERY DEPLETION, THE SETSCREW WAS FOUND TO BE STUCK. SUBSEQUENTLY, A DRILL WAS USED TO SUCCESSFULLY REMOVE THE LEAD FROM THE HEADER. EVENTUALLY, THIS S-ICD WAS RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16457435 ↗
• MalfunctionFeb 27, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING ROUTINE REPLACEMENT OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD), DIFFICULTY WAS ENCOUNTERED WITH LOOSENING THE SET SCREW TO REMOVE THE ELECTRODE FROM THE DEVICE HEADER. MULTIPLE TORQUE WRENCHES AND TECHNIQUES WERE ATTEMPTED, HOWEVER, THE SET SCREW WAS UNABLE TO BE LOOSENED. THE PHYSICIAN THEN TUGGED ON THE ELECTRODE AND IT CAME OUT OF THE DEVICE HEADER. THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 16446517 ↗
• MalfunctionFeb 23, 2023Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE CHANGE OUT PROCEDURE OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD), DIFFICULTY WAS EXPERIENCED WITH LOOSENING A SET SCREW WITH A TORQUE WRENCH TO REMOVE THE S-ICD FROM THE ELECTRODE. IT WAS RECOMMENDED TO REMOVE THE BACK OF THE HEADER BY CUTTING, TO REMOVE THE S-ICD. THE PHYSICIAN WAS ABLE TO REMOVE THE ELECTRODE WITHOUT ANY DAMAGE AND THE S-ICD WAS SUCCESSFULLY REPLACED WITH A NEW ONE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16432317 ↗
• MalfunctionFeb 22, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) REPLACEMENT PROCEDURE, THE TORQUE WRENCH WOULD START CLICKING WHEN THE PHYSICIAN WAS ATTEMPTING TO TURN THE SET SCREW. THE PHYSICIAN WAS EVENTUALLY ABLE TO REMOVE THE ELECTRODE WITHOUT ANY OTHER ISSUE AND THE REPLACEMENT PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS S-ICD IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16421431 ↗
• MalfunctionFeb 22, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING ROUTINE REPLACEMENT OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD), DIFFICULTY WAS ENCOUNTERED WITH LOOSENING THE SET SCREW TO REMOVE THE ELECTRODE FROM THE DEVICE HEADER. TWO TORQUE WRENCHES WERE BENT DURING ATTEMPTS TO LOOSEN THE SET SCREW, HOWEVER, IT WAS ABLE TO BE LOOSENED AFTER SEVERAL ATTEMPTS. THE ELECTRODE WAS SUCCESSFULLY REMOVED FROM THE DEVICE HEADER. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT IS IN HOSPITAL POSSESSION AND IS NOT EXPECTED TO BE RETURNED AT THIS TIME. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED AT THAT TIME.

  Patient problems: Insufficient Information

  MAUDE report 16417043 ↗
• MalfunctionFeb 21, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING ROUTINE REPLACEMENT OF THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD), DIFFICULTY WAS ENCOUNTERED WITH LOOSENING THE SET SCREW TO REMOVE THE ELECTRODE FROM THE DEVICE HEADER. TROUBLESHOOTING WAS PERFORMED AND THE SET SCREW WAS ABLE TO BE LOOSENED AND THE ELECTRODE SUCCESSFULLY REMOVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 16414748 ↗
• MalfunctionFeb 20, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING AN EXPLANT PROCEDURE FOR NORMAL BATTERY DEPLETION, THE SETSCREWS ON THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WERE STUCK. THE PHYSICIAN WAS ABLE TO FREE THE SETSCREWS AFTER HEARING A RATCHETING SOUND. THIS S-ICD WAS SUCCESSFULLY EXPLANTED, REPLACED, AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404225 ↗
• MalfunctionFeb 20, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE SETSCREWS ON THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WERE STUCK DURING AN EXPLANT PROCEDURE FOR NORMAL BATTERY DEPLETION. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED, AND TS PROVIDED POSSIBLE SOLUTIONS. THEY TRIED DIFFERENT TORQUE WRENCHES, HEPARINIZED SALINE TURNING CLOCKWISE AND THEN COUNTERCLOCKWISE, BUT THE SETSCREWS REMAINED STUCK. THEY WERE EVENTUALLY ABLE TO GET THE SETSCREW LOOSE. THE S-ICD WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404186 ↗
• MalfunctionFeb 20, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) CHANGEOUT PROCEDURE DUE TO NORMAL BATTERY DEPLETION, THE SETSCREWS GOT STUCK. THE S-ICD WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16403671 ↗
• InjuryDec 26, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WERE CONCERNS THE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS EXPERIENCING PREMATURE BATTERY DEPLETION (PBD). THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16048714 ↗
• InjuryJun 30, 2022High impedance; High impedance

  IT WAS REPORTED THAT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) AND ELECTRODE EXHIBITED ELEVATED SHOCK IMPEDANCE MEASUREMENTS OF 155 OHMS. TECHNICAL SERVICES (TS) DISCUSSED POTENTIAL CAUSES AND TROUBLESHOOTING OPTIONS. ADDITIONAL INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED. THE DEVICE POCKET WAS OPENED AND WAS REPOSITIONED TO OBTAIN MORE CONTACT WITH THE FACIA. IT WAS REPORTED THAT THE PATIENT HAD GAINED A SIGNIFICANT AMOUNT OF WEIGHT SINCE IMPLANT, AND THE PHYSICIAN BELIEVED THAT THERE WAS A LOT OF AIR IN THE POCKET DUE TO THE CHANGE IN BODY MASS INDEX. AFTER THE DEVICE WAS REPOSITIONED SHOCK IMPEDANCE MEASUREMENTS WERE NOTED TO BE 185 OHMS. THE POCKET WAS THEN FLUSHED AND SHOCK IMPEDANCE MEASUREMENTS DECREASED TO 175 OHMS. A 10 JOULE SHOCK WAS DELIVERED AND SHOCK IMPEDANCE MEASUREMENTS WERE NOTED TO BE 195 OHMS. THE PHYSICIAN CLOSED THE POCKET AND WAS CONSIDERING REFERRING THE PATIENT FOR POTENTIAL ELECTRODE EXPLANT. ADDITIONALLY, THE DEVICE WAS NOTED TO HAVE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14881053 ↗
• MalfunctionJun 15, 2022Connection Problem; Material Integrity Problem; Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT AT THE ELECTIVE PROCEDURE TO EXPLANT THIS SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD), THE ELECTRODE COULD NOT BE REMOVED FROM THE DEVICE HEADER DUE TO A STUCK SETSCREW. A COMPETITIVE RATCHETING WRENCH AND NON RATCHETING WRENCH WERE BOTH USED WITHOUT SUCCESS. THE NON RATCHETING WRENCH BECAME BENT DURING THE EFFORTS. THE HEADER WAS DETACHED FROM THE DEVICE AND THE PHYSICIAN WAS ABLE TO BORE THE SETSCREW DOWN WITH A SCREW REMOVAL KIT. THE PIN WAS FINALLY RELEASED FROM THE HEADER. THE ELECTRODE FUNCTIONED NORMALLY AND A REPLACEMENT S-ICD WAS IMPLANTED WITHOUT FURTHER INCIDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14691498 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P110042. One submission often covers many models, so check the product and lot details in each record.

• Z-2441-2023 · Jul 11, 2023 · Open, Classified
  EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
• Z-2442-2023 · Jul 11, 2023 · Open, Classified
  EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator
• Z-0152-2023 · Sep 30, 2022 · Open, Classified
  EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
• Z-0151-2023 · Sep 30, 2022 · Open, Classified
  EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
• Z-0474-2019 · Nov 1, 2018 · Terminated
  The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System The S-ICD System is intended to provide defibrillation therapy for
• Z-3038-2017 · Jun 29, 2017 · Terminated
  EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the trea
• Z-3037-2017 · Jun 29, 2017 · Terminated
  EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatmen
• Z-3039-2017 · Jun 29, 2017 · Terminated
  SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias i
• Z-1178-2017 · Jan 12, 2017 · Terminated
  Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.
• Z-0232-2016 · Sep 17, 2015 · Terminated
  Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.
• Z-0965-2013 · Mar 1, 2013 · Terminated
  Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular t