PLATINIUM CRT-D 1741Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08031527015484), received between Aug 4, 2017 and Apr 7, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

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 16, 2026.

Recalls naming this device

1. Jul 9, 2018Terminated

   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-2825-2018 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2021Over-Sensing; Over-Sensing

  IT WAS REPORTED ON (B)(6) 2021 THAT THE PATIENT COMPLAINED OF OCCASIONAL SYMPTOMATIC LIGHT HEADEDNESS. INTERROGATING THE CRT-D REVEALED SEVERAL MODE SWITCH EPISODES WITH ABSENCE OF TRUE ATRIAL ARRHYTHMIA. THE PATIENT HAD A HISTORY OF MINOR ATRIAL OVERSENSING THAT WAS PREVIOUSLY MANAGED BY DECREASING THE ATRIAL SENSITIVITY; HOWEVER, THE STORED EPISODES SEEN ON (B)(6) 2021 REVEALED MORE OVERSENSING THAT BEFORE. PROVOCATIVE TESTING WAS PERFORMED AND THE NOISE ON THE ATRIAL CHANNEL WAS REPRODUCED ALONG WITH VENTRICULAR OVERSENSING WHEN THE PATIENT WAS LYING ON THE BACK, WITH THE HEAD TURNING FROM SIDE TO SIDE. THE NOISE WAS NOT REPRODUCED VIA ISOMETRICS, VALSALVA MANEUVERS, DEEP RESPIRATION OR COUGHING. POST-V AND POST-R REFRACTORY PERIODS WERE SET TO 155MS AND THE VENTRICULAR SENSITIVITY WAS REPROGRAMMED TO 0.8MV. FOLLOWING THESE ADJUSTMENTS, FURTHER VENTRICULAR OVERSENSING WAS UNABLE TO BE REPRODUCED AND THE IMPACT ON THE INAPPROPRIATE MODE SWITCH WILL BE MONITORED OVER TIME. EVALUATION OF THE POSITION AND PERFORMANCE OF THE LEADS, ESPECIALLY THE ATRIAL LEAD WILL BE SCHEDULED.

  Patient problems: Dizziness

  MAUDE report 11630960 ↗
• InjuryMar 5, 2020Premature Discharge of Battery; High Capture Threshold; Premature Discharge of Battery; High Capture Threshold

  REPORTEDLY, THE SUBJECT CRT-D AND ASSOCIATED LEFT VENTRICULAR LEAD WERE EXPLANTED ON (B)(6) 2019. THE RE-INTERVENTION WAS PERFORMED DUE TO A HIGH LEFT VENTRICULAR CAPTURE THRESHOLD. AS THE CRT-D ESTIMATED RESIDUAL LONGEVITY WAS LESS THAN A YEAR, IT WAS DECIDED TO REPLACE IT AT THE SAME TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9793712 ↗
• InjuryNov 8, 2019Unclear Information; Unclear Information

  A "GENERATOR FAILURE" WAS REPORTED TO HAVE OCCURRED. THIS DEVICE IS UNDER THE ADVISORY OF THE FIELD SAFETY NOTICE OF JULY 2018 ON PLATINUM DEVICES.

  Patient problems: No Information

  MAUDE report 9296622 ↗
• InjuryAug 4, 2017Contamination /Decontamination Problem; Contamination /Decontamination Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 6766580 ↗

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-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-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-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