ECG Cable 3mRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08031527013916), received between Apr 4, 2018 and Dec 17, 2020 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (4 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 18, 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.

• InjuryDec 17, 2020High impedance; Delayed Charge Time; High impedance; Delayed Charge Time

  THE DEFIBRILLATION SYSTEM WAS IMPLANTED ON (B)(6) 2016. REPORTEDLY, AN ALERT STATING THAT THE VENTRICULAR LEAD IMPEDANCE WAS SATURATED AT 3000 OHMS ON (B)(6) 2020 WAS TRANSMITTED BY REMOTE MONITORING ON (B)(6) 2020. AS A RESULT, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A FOLLOW-UP ON (B)(6) 2020. THE VENTRICULAR LEAD IMPEDANCE WAS MEASURED AT 2700 OHMS, BUT THE RV COIL CONTINUITY TREND WAS WITHIN NORMAL RANGE. THE BATTERY VOLTAGE WAS MEASURED AT 2.95 V ON (B)(6) 2020, AND THE LAST CHARGE TIME RECORDED IN (B)(6) 2020 WAS 14.5 S. PRELIMINARY ANALYSIS REVEALED THAT THE REPORTED BEHAVIOR MOST PROBABLY RESULTED FROM A GRADUAL VENTRICULAR LEAD ISSUE OR A GRADUAL PHYSIOLOGICAL PHENOMENON OCCURRING AT THE IMPLANT SITE. FOLLOWING THE RECOMMENDATIONS SENT ON 30 NOVEMBER 2020, THE ASSOCIATED VENTRICULAR LEAD WAS REPLACED ON (B)(6) 2020. HOWEVER, POSSIBLE FIBROSIS AROUND THE LEAD TIP AND THE COIL PREVENTED ITS EXTRACTION. AS A RESULT, THE VENTRICULAR LEAD WAS ABANDONED IN PATIENT'S BODY. IT WAS DECIDED TO EXPLANT THE ICD DURING THE SAME MEDICAL PROCEDURE, CONSIDERING ITS REMAINING RESIDUAL LONGEVITY.

  Patient problems: No Information

  MAUDE report 11026264 ↗
• MalfunctionNov 12, 2020Over-Sensing; Over-Sensing

  DURING A FOLLOW-UP PERFORMED ON (B)(6) 2020, NOISE OVERSENSING WAS OBSERVED IN SEVERAL EPISODES RECORDED IN THE DEVICE MEMORY ON (B)(6) 2020 AND (B)(6) 2020. MANEUVERS WERE PERFORMED, BUT THE OBSERVED NOISE COULD NOT BE REPRODUCED. THE PATIENT REPORTED THAT HE HAD NOT BEEN EXPOSED TO EXTERNAL INTERFERENCES. A NEW-FOLLOW-UP WAS SCHEDULED IN THREE MONTHS. IN THE MEANTIME, THE PATIENT SHOULD BE REMOTELY MONITORED.

  Patient problems: No Information

  MAUDE report 10828487 ↗
• InjuryNov 5, 2020Over-Sensing; Over-Sensing

  REPORTEDLY, SEVERAL EPISODES OF VENTRICULAR NOISE OVERSENSING WERE OBSERVED WITHOUT LEADING TO SUSTAINED VF OR THERAPY DELIVERY. STRESS TESTS WERE PERFORMED AND THE NOISE WAS REPRODUCED.

  Patient problems: No Information

  MAUDE report 10792754 ↗
• MalfunctionJan 21, 2020Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  THE DEFIBRILLATION SYSTEM WAS IMPLANTED ON (B)(6) 2015. REPORTEDLY, THERAPIES WERE DELIVERED SO THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2019 FOR A REVIEW, WHICH REVEALED NOISE OVERSENSING. THE ELECTRODE WAS CHECKED WITH FLUOROSCOPY AND NO DAMAGE WAS OBSERVED. THE PHYSICIAN DECIDED TO DEACTIVATE ATP AND SHOCK THERAPIES TO MONITOR THE PATIENT. A FOLLOW-UP WAS SCHEDULED FOR (B)(6) 2020. ON (B)(6) 2020, THE DEFIBRILLATION SYSTEM WAS EXPLANTED AND SHOULD BE RETURNED FOR ANALYSIS. DURING THE PROCEDURE, IT WAS NOT POSSIBLE TO EXPLANT THE LEAD BY USING A STYLET AND RETRACTING THE HELIX. THEREFORE, THE LEAD WAS EXPLANTED USING ANOTHER SYSTEM. THE PHYSICIAN REPORTED THAT THE DAMAGE ON THE EXTERNAL COIL WAS DUE TO THE EXTRACTION MANEUVERS, HOWEVER THE FILAMENT ON THE PROXIMAL COIL WAS NOT CAUSED BY THE PROCEDURE. PRELIMINARY ANALYSIS REVEALED THAT THE NOISE OVERSENSING WAS MOST PROBABLY DUE TO A VENTRICULAR LEAD ISSUE.

  Patient problems: No Information

  MAUDE report 9611285 ↗
• InjuryDec 27, 2018Over-Sensing; Over-Sensing

  ON (B)(6) 2016, THE SUBJECT IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) WAS IMPLANTED WITH A VOLTA 1CR65. ON (B)(6) 2018, NOISE ON THE RIGHT VENTRICULAR CHANNEL WAS DETECTED DURING THE FOLLOW-UP AND IN THE REMOTE FOLLOW-UP, SUGGESTING SOME LEAD ISSUE. THE PHYSICIAN DECIDED THE REPLACEMENT OF ALL THE SYSTEM TAKING INTO ACCOUNT THE PATIENT AGE AND THE ICD RESIDUAL LONGEVITY. ON (B)(6) 2018, THE SUBJECT ICD AND VOLTA LEAD HAVE BEEN EXPLANTED AND REPLACED. THE PHYSICIAN IS ASSUMING THAT THE LEAD WAS BROKEN BECAUSE THE PATIENT IS PRACTICING GYMNASTIC WITH WEIGHTS. THE PRELIMINARY ANALYSIS SUGGESTS THAT THE REPORTED EVENT IS DUE TO A LEAD ISSUE.

  Patient problems: No Information

  MAUDE report 8199169 ↗
• InjuryNov 21, 2018Low impedance; Low impedance

  ON (B)(6) 2018, DURING A FOLLOW-UP, NOISE ON THE VENTRICULAR CHANNEL AND LOW RIGHT VENTRICULAR LEAD IMPEDANCE VALUES (BELOW 200 OHMS) WERE DETECTED. A BREAKAGE OF THE LEAD (VOLTA 1CR65) WAS SUSPECTED, SO THE PATIENT WAS ADMITTED AT THE HOSPITAL AND A RE-INTERVENTION WAS SCHEDULED FOR (B)(6). ON (B)(6) 2018, BEFORE AND DURING THE RE-INTERVENTION, THE IMPEDANCES WERE MEASURED AGAIN AND THE MEASUREMENTS WERE NORMAL. THE PHYSICIAN DECIDED TO EXPLANT THE SUBJECT DEVICE, AS WELL AS THE VENTRICULAR LEAD, GIVEN THE RESIDUAL LONGEVITY OF THE ICD.

  Patient problems: No Information

  MAUDE report 8094962 ↗
• InjuryApr 16, 2018Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  ON (B)(6) 2018, THE PATIENT WENT TO EMERGENCY SERVICE AND WAS ADMITTED AT HOSPITAL BECAUSE THE DEVICE WAS DELIVERING INAPPROPRIATE SHOCKS DUE TO NOISES IN RIGHT VENTRICULAR CHANNEL. THE THERAPIES WERE DEACTIVATED AND THE PATIENT REMAINED ADMITTED AT THE HOSPITAL. AS A CONSEQUENCE THE FOLLOWING REMOTE FOLLOW-UPS WERE CHECKED: ON (B)(6) 2018, THE ¿V OVERSENSING SUSPECTED¿ REMOTE WARNING WAS RECEIVED WITH RESPECTIVELY 23, 2 AND 3 NON TREATED EVENTS . THE REPORTS SHOWED A DROP OF THE VENTRICULAR SENSING AND SOME ABNORMAL RIGHT VENTRICULAR IMPEDANCE LEAD VALUES. THE EGM¿S EVENTS SHOWED NOISE IN THE RIGHT VENTRICULAR CHANNEL TOO. FINALLY ON (B)(6) 2018, THE RE-INTERVENTION WAS PERFORMED SUSPECTING OF A LEAD/CONNECTION ISSUE. THE LEAD VOLTA 1CR65, S/N (B)(4), WAS CHECKED SEVERAL TIMES WITH THE MEDTRONIC PACING SYSTEM ANALYZER AND IT SEEMED THAT THE LEAD WAS OK, SINCE NO NOISES WERE DETECTED WHEN MOVING THE PATIENT ARM AND THE IMPEDANCE AND DETECTION VALUES WERE STABLE AND CORRECT. BOTH THE SUBJECT DEVICE AND THE VENTRICULAR LEAD WERE EXPLANTED WITHOUT PROBLEMS.

  Patient problems: No Information

  MAUDE report 7432244 ↗
• MalfunctionApr 4, 2018High impedance; High impedance

  REPORTEDLY, DURING A FOLLOW-UP PERFORMED ON (B)(6) 2018, A SUDDEN INCREASE IN THE VENTRICULAR LEAD IMPEDANCE CURVE, UP TO 3000 OHMS, WAS OBSERVED AROUND (B)(6) 2018. THE VENTRICULAR LEAD IMPEDANCE MEASUREMENTS DECREASED IN (B)(6) 2018 AND WERE WITHIN NORMAL RANGE DURING THE FOLLOW-UP PERFORMED ON (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7395862 ↗