C/IS-10 SS2Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885672102739), received between Jun 12, 2017 and May 22, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Impedance Problem” (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.

• MalfunctionMay 22, 2024Over-Sensing; Over-Sensing

  THE CUSTOMER REOPENED THIS COMPLAINT FROM A VINTAGE SYSTEM; REPORTED EVENT DATE IS 2014-10-14. THE CUSTOMER RECEIVED INFORMATION THAT THIS PATIENT EXHIBITED SOME MYOPOTENTIALS IN BOTH THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEADS. THE RA LEAD IS BELIEVED TO BE A NON-BOSTON SCIENTIFIC LEAD. WE HAVE NO INFORMATION REGARDING THE LEAD. OUR DEVICE IS L331/972384. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND STATED THAT SINCE THIS IS A PACEMAKER DEPENDENT PATIENT, THEY CAN RAISE THE SENSING TO 10 TO ELIMINATE THE ISSUE, THEY MIGHT STILL SEE SOME OVERSENSING. THE HEALTH CARE PROFESSIONAL (HCP) ELECTED TO LEAVE AT A SETTING OF 1.5 TO ELIMINATE OVERSENSING ON THE ATRIAL LEAD, BUT STILL WANTED TO SEE P-WAVES. TS STATED THIS IS NORMAL OPERATION FOR THESE UNIPOLAR LEADS. CURRENTLY BOTH LEADS REMAIN IMPLANTED. THE ONLY INFORMATION WE HAVE REGARDING THESE LEADS ARE THE ADAPTERS LISTED. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE RA LEAD WITH THIS ADAPTER EXHIBITED OVERSENSING OF MYOPOTENTIAL NOISY SIGNALS THAT RESULTED IN INAPPROPRIATE MODE SWITCHES AND PACING INHIBITION. THE HEALTH CARE PROFESSIONAL (HCP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19375275 ↗
• MalfunctionApr 18, 2018Impedance Problem; Impedance Problem

  REPORTER RECEIVED A CALL ON (B)(6) 2018, THAT INDICATED THE MALE PATIENT, (B)(6) WAS IN CLINIC AND BROUGHT THEIR COMMUNICATOR, WHICH DISPLAYED A RED CALL DOCTOR ICON. PATIENT SERVICES ASSISTED THE HEALTH CARE PROFESSIONAL WITH SUCCESSFULLY CONNECTING THE COMMUNICATOR TO THE SERVER. A RED ALERT POSTED FOR OUT OF RANGE RV PACING IMPEDANCE MEASUREMENTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER AT THE TIME OF THIS REPORT NO FURTHER INFORMATION IS AVAILABLE REGARDING THE PRODUCT NOR THE INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7439537 ↗
• InjuryOct 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS ADAPTER WAS EXPLANTED (B)(6) 2017 DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6964520 ↗
• InjuryOct 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DESCRIPTION: 479-01/(B)(4)- INFECTION - EXPLANTED; 493-04/(B)(4) - INFECTION - EXPLANTED; C/IS/(B)(4) - INFECTION - EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 6964510 ↗
• InjuryJun 12, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE BRADY ADAPTER WAS EXPLANTED DUE TO AN UNKNOWN PRODUCT PERFORMANCE ISSUE.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 6635004 ↗