PLATINIUM CRT-D 1711Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08031527015538), received between Nov 14, 2017 and Jan 18, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (2 reports).

1 FDA recall record name this device's identifier.

3 other recalls cover devices cleared under the same FDA submission (P060027); 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 18, 2026.

Recalls naming this device

1. Jul 9, 2018Class IITerminated

   Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. The device then cannot identify an arrhythmia that would require defibrillation shock therapy.

   Z-2824-2018 · Root cause: Component design/selection · Recall details · FDA record ↗

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.

• MalfunctionJan 18, 2024Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  REPORTEDLY, DURING THE INTERROGATION OF THE SUBJECT DEVICE, THE FOLLOWING WARNING MESSAGES WERE DISPLAYED - [27], [A26] AND [A3] INDICATING THE DEVICE HAD BEEN RESET 1 TIME SINCE BEGINNING OF LIFE ON DEC 6, 2023 STATING THE DEFIBRILLATION SYSTEM POTENTIALLY INEFFECTIVE. THE PATIENT WAS SENT HOME. THE CHARGE TIME WAS 13 SECONDS TODAY WITH A BATTERY VOLTAGE OF 2.9V. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18535530 ↗
• InjuryMar 5, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  REPORTEDLY, ON (B)(6) 2020, THE PATIENT WENT TO THE HOSPITAL FOLLOWING SHOCKS. A MAGNET HAS BEEN APPLIED ON THE DEVICE FOR A WEEK; HOWEVER, WHEN REMOVING THE MAGNET, THE PATIENT RECEIVED SHOCKS AGAIN. A LEAD FRACTURE IS SUSPECTED. PRELIMINARY ANALYSIS CONFIRMED THE PRESENCE OF VENTRICULAR NOISE OVERSENSING EPISODES LEADING TO INAPPROPRIATE SHOCKS DELIVERIES. THIS NOISE OVERSENSING MOST PROBABLY RESULTED FROM A VENTRICULAR LEAD ISSUE AND/OR CONNECTION ISSUE; HOWEVER, NONE OF THEM COULD BE CONFIRMED WITH CERTAINTY.

  Patient problems: No Information

  MAUDE report 9793477 ↗
• InjuryDec 27, 2019High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  REPORTEDLY, SEVERAL WARNINGS WERE DISPLAYED ON THE OVERVIEW SCREEN DURING A FOLLOW-UP PERFORMED ON 03 DECEMBER 2019. MOREOVER, NOISE OVERSENSING WAS OBSERVED ON THE ATRIAL AND VENTRICULAR CHANNELS IN THE RECORDED EPISODES. THE ASSOCIATED RV LEAD WAS IMPLANTED FOLLOWING THE RE-INTERVENTION PERFORMED ON (B)(6) 2018 TO REPLACE THE PREVIOUSLY IMPLANTED RV LEAD. PRELIMINARY ANALYSIS RESULTS SHOWED NON-PHYSIOLOGICAL SIGNALS IN THE ATRIAL AND VENTRICULAR CHANNELS, LEADING TO THE REPORTED NOISE OVERSENSING IN BOTH CHANNELS AND THE DELIVERY OF TWO INAPPROPRIATE SHOCKS. THE OBSERVED NOISE MOST PROBABLY RESULTED FROM LEADS ISSUES AND/OR LEADS/CRT-D CONNECTION ISSUES.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 9523167 ↗
• InjuryJul 13, 2018Over-Sensing; Defibrillation/Stimulation Problem; Over-Sensing; Defibrillation/Stimulation Problem

  REPORTEDLY, EPISODES SHOWING VENTRICULAR OVERSENSING WERE OBSERVED IN THE DEVICE MEMORIES DURING A ROUTINE FOLLOW-UP PERFORMED ON (B)(6) 2018. IN ONE EPISODE, A SHOCK WAS TRIGGERED BUT COULD NOT BE DELIVERED DUE TO OVERLOAD DETECTION. PRELIMINARY ANALYSIS CONFIRMED THE REPORTED ISSUE AND SHOWED THAT IT WAS MOST PROBABLY DUE TO A DEFIBRILLATION LEAD ISSUE. BASED ON AVAILABLE DATA, NO ISSUE IS SUSPECTED ON THE ICD. RECOMMENDATIONS TO REPLACE THE DEFIBRILLATION LEAD WERE SENT ON (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7685877 ↗
• InjuryNov 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ENTIRE SYSTEM WAS EXPLANTED DUE TO INFECTION ON (B)(6) 2017. AN INVESTIGATION IS REQUIRED.

  Patient problems: Unspecified Infection

  MAUDE report 7027692 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P060027. One submission often covers many models, so check the product and lot details in each record.

• Z-3233-2017 · Jul 24, 2017 · Terminated
  Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single c
• Z-3230-2017 · Jul 24, 2017 · Terminated
  Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single
• Z-2579-2010 · Jun 7, 2010 · Terminated
  Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770. Made in Italy by Sorin Biomedical CRM S.r.l. Via Crescentino s.n. , 13040 Saluggia (VC) Italy