Current Accel™ VR (REF CD1215-36)Recalls & reported problems
St. Jude Medical, Inc. · Tiered-therapy cardioverter/defibrillator VVEV VVIR · Class 3 · Implant
All models of Current Accel (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05414734502634), received between Jun 18, 2018 and Oct 16, 2020 — classified as 9 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Premature Discharge of Battery” (8 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
Device problems
- Premature Discharge of Battery8
- Adverse Event Without Identified Device or Use Problem3
- Premature Elective Replacement Indicator3
- Component Missing1
- Data Problem1
- Defective Alarm1
- Failure to Charge1
- Inappropriate/Inadequate Shock/Stimulation1
Patient problems
- No Known Impact Or Consequence To Patient16
- No Information2
- No Consequences Or Impact To Patient1
- Therapeutic Effects, Unexpected1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjuryOct 16, 2020Premature Discharge of Battery; Premature Discharge of Battery
DURING AN IN-CLINIC FOLLOW UP, IT WAS SUSPECTED THAT THERE WAS PREMATURE BATTERY DEPLETION ON THE DEVICE. THE DEVICE WAS EXPLANTED AND REPLACED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10690631 ↗MalfunctionMar 16, 2020Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THE PATIENT PRESENTED IN CLINIC ON (B)(6) 2020. IT WAS NOTED THAT THE DEVICE REACHED ERI ON (B)(6) 2019. THE LAST TRANSMISSION IN (B)(6) 2019 AND IN PERSON IN (B)(6) 2019 HE HAD AN ESTIMATED 9 MONTHS LEFT ON THE BATTERY. PREMATURE DEPLETION WAS SUSPECTED. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS STABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9836437 ↗InjuryFeb 17, 2020Failure to Charge; Failure to Charge
DURING FOLLOW-UP, A CAPACITOR CHARGE TIME OUT WAS OBSERVED. THE PATIENT WAS STABLE WITH ADVERSE CONSEQUENCES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9716703 ↗MalfunctionJul 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS IS TO REPORT OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: No Information
MAUDE report 8849089 ↗MalfunctionJul 23, 2019Premature Discharge of Battery; Incorrect Measurement; Premature Discharge of Battery; Incorrect Measurement
DURING FOLLOW-UP, PREMATURE BATTERY DEPLETION WAS SUSPECTED. NO INTERVENTION HAS BEEN PERFORMED, THE DEVICE REMAINS IMPLANTED AND WILL CONTINUE TO BE MONITORED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8816248 ↗InjuryJul 18, 2019Premature Discharge of Battery; Premature Discharge of Battery
THE PATIENT RECEIVED A VIBRATORY ALERT AND PRESENTED IN CLINIC FOR A FOLLOW UP. PREMATURE BATTERY DEPLETION WAS SUSPECTED. NO INTERVENTION HAS BEEN PERFORMED, DEVICE EXPLANT AND REPLACEMENT IS ANTICIPATED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8804768 ↗MalfunctionJul 3, 2019Unexpected Therapeutic Results; Unexpected Therapeutic Results
DURING A FOLLOW-UP, INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) ON THE DEVICE WAS NOTED. THE DEVICE WAS REPROGRAMMED. THE PATIENT WAS STABLE WITH NO ADVERSE CONSEQUENCES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8760372 ↗MalfunctionApr 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Patient problems: No Information
MAUDE report 8507148 ↗InjuryMar 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED VIA REMOTE TRANSMISSION WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AT ELECTIVE REPLACEMENT INDICATOR. BASED ON LONGEVITY ESTIMATES, PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE PHYSICIAN EXPLANTED AND REPLACED THE DEVICE WITH NO COMPLICATIONS. FURTHER INVESTIGATION REVEALED, THAT THE PROGRAMMER HAD OVERESTIMATED THE BATTERY LONGEVITY AND THAT THE DEVICE BATTERY DEPLETION WAS NORMAL. THE PATIENT WAS STABLE AND DOING WELL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8426485 ↗MalfunctionFeb 11, 2019Defective Alarm; Defective Alarm
IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR ROUTINE FOLLOW UP. DURING DEVICE INTERROGATION, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DID NOT EXHIBIT ANY VIBRATORY ALERTS DESPITE MULTIPLE ATTEMPTS BY THE NURSE. NO INTERVENTIONS WAS PERFORMED. THE PATIENT REMAINED STABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8326646 ↗InjuryFeb 11, 2019Premature Discharge of Battery; Over-Sensing; Premature Discharge of Battery; Over-Sensing
DURING FOLLOW-UP, THE DEVICE WAS INTERROGATED AND PREMATURE BATTER DEPLETION WAS SUSPECTED. POST PACED T-WAVE OVERSENSING WAS ALSO NOTED. THE DEVICE WAS EXPLANTED. THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8325755 ↗InjuryDec 19, 2018Premature End-of-Life Indicator; Premature Elective Replacement Indicator; Premature End-of-Life Indicator; Premature Elective Replacement Indicator
IT WAS REPORTED THAT A RAPID ERI TO EOL PERIOD WAS OBSERVED. IT WAS UNABLE TO DETERMINE THE REASON FOR THE RAPID VOLTAGE DROP FOLLOWING ERI. ON (B)(6) 2018, THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION IS FINE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8181865 ↗MalfunctionDec 4, 2018Data Problem; Data Problem
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED A LONGEVITY ESTIMATE OF 3 YEARS DURING DEVICE CHECK IN (B)(6) 2018. DURING A DEVICE INTERROGATION ON 11/20/18, THE DEVICE EXHIBITED A LONGEVITY ESTIMATE OF LESS THAN 3 MONTHS. THE PHYSICIAN WAS NOT CONCERNED WITH THE DIAGNOSTICS ANOMALY AS THE BATTERY DEPLETION TREND LOOKED NORMAL. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8129858 ↗InjuryNov 15, 2018Premature Discharge of Battery; Premature Discharge of Battery
DURING A FOLLOW-UP IN CLINIC, THE DEVICE WAS INTERROGATED AND THE REMAINING LONGEVITY WAS MUCH LOWER THAN EXPECTED. IT WAS SPECULATED THAT THE REMAINING LONGEVITY MAY HAVE BEEN OVERESTIMATED AT THE PREVIOUS FOLLOW-UP APPOINTMENT. THE DEVICE WAS EXPLANTED AND REPLACED AND THE PATIENT WAS STABLE WITH NO CONSEQUENCES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8073759 ↗MalfunctionOct 22, 2018Premature Discharge of Battery; Premature Discharge of Battery
DURING A FOLLOW-UP, UPON INTERROGATION, AN ALERT FOR THE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS DISPLAYED DUE TO SUSPECTED PREMATURE BATTERY DEPLETION AS THE LONGEVITY OF THE DEVICE HAD DROPPED UNEXPECTEDLY. NO FURTHER INTERVENTION WAS PERFORMED AT THIS TIME AND THE DEVICE WILL CONTINUE TO BE MONITORED UNTIL EXPLANT. THE PATIENT WAS STABLE WITH NO ADVERSE CONSEQUENCES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7990812 ↗InjuryOct 2, 2018Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
THE DEVICE WAS EXPLANTED TO RESOLVE THE EVENT AND THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7927532 ↗MalfunctionSep 14, 2018Component Missing; Component Missing
DURING IMPLANT PROCEDURE, THE PHYSICIAN NOTED THAT THE SILICONE SEAL COVERING THE SET SCREW ON THE DEVICE HEADER WAS MISSING. A NEW DEVICE WAS IMPLANTED AND THE PATIENT WAS IN STABLE CONDITION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7877664 ↗MalfunctionJul 19, 2018Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation
DURING A FOLLOW-UP IN CLINIC, THE DEVICE WAS INTERROGATED AND THERE WERE EPISODES OF INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) NOTED. THE ATP WAS DELIVERED FOR AN ATRIAL FIBRILLATION (AF) BUT THE SHOCK WAS ABORTED DUE TO A RETURN TO SINUS. THE DEVICE WAS REPROGRAMMED AND THE PATIENT WAS STABLE.
Patient problems: Therapeutic Effects, Unexpected
MAUDE report 7704115 ↗MalfunctionJul 12, 2018Premature Elective Replacement Indicator; Premature Elective Replacement Indicator
DURING A FOLLOW-UP, THE DEVICE WAS INTERROGATED AND REVEALED TWO ALERTS FOR ELECTIVE REPLACEMENT INDICATOR (ERI). ONE OF THE ERI ALERTS WAS INCORRECTLY DELIVERED. THE DEVICE WAS EXPLANTED AND REPLACED DUE TO NORMAL ERI AND THE PATIENT WAS STABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7681325 ↗InjuryJun 18, 2018Premature Discharge of Battery; Premature Discharge of Battery
NEW INFORMATION AVAILABLE ON (B)(6) 2018 STATES THAT THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE BEFORE, DURING AND POST PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7610180 ↗
Other Pulse generator, permanent, implantable devices
- Assurity™ PM2240St. Jude Medical, Inc. · Pulse generator, permanent, implantable1 recall84 deaths4,076 reports
- Fortify Assura™ CD2357-40QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable63 deaths3,571 reports
- Advisa DR MRI™ SureScan® A2DR01Medtronic, Inc. · Pulse generator, permanent, implantable51 deaths2,298 reports
- Fortify Assura™ CD1357-40QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable35 deaths1,933 reports
- Ellipse™ CD2411-36QSt. Jude Medical, Inc. · Pulse generator, permanent, implantable42 deaths1,498 reports
- Fortify Assura™ CD2357-40CSt. Jude Medical, Inc. · Pulse generator, permanent, implantable25 deaths1,378 reports
- Accent® DR RFSt. Jude Medical, Inc. · Pulse generator, permanent, implantable73 deaths1,370 reports
- Edora 8 DR-T 407145BIOTRONIK SE & Co. KG · Pulse generator, permanent, implantable10 deaths982 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page