PLATINIUMRecalls & reported problems across all models

We found 4 models of PLATINIUM by Microport Crm Srl in the FDA's device registry (GUDID). Together they are named in 14 adverse event reports in the FDA's MAUDE database, received between Feb 9, 2017 and Jan 18, 2024 — classified as 13 injuries, 1 malfunction.

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

2 FDA recall records name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

PLATINIUM recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 ↗

2. 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-2824-2018 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported PLATINIUM problems

PLATINIUM models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PLATINIUM CRT-D 1711

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall5 reports
• PLATINIUM CRT-D 1741

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall4 reports
• PLATINIUM DR 1510

  DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
  3 reports
• PLATINIUM VR 1210

  DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
  2 reports

Recent PLATINIUM adverse event reports

The 14 most recent reports across all models, 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 ↗
• 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 ↗
• InjuryDec 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  REPORTEDLY, ON (B)(6) 2020, THE SUBJECT ICD WAS REPLACED AS IT WAS MALFUNCTIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10993357 ↗
• 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 ↗
• 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 ↗
• 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 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, ON (B)(6)2019 , THE SUBJECT ICD WAS EXPLANTED DUE TO A POCKET INFECTION. PRELIMINARY ANALYSIS REVEALED THAT THE SUBJECT DEVICE HAS BEEN STERILIZED AND RELEASED ACCORDING TO ALL APPLICABLE PROCEDURES.

  Patient problems: Unspecified Infection

  MAUDE report 8874326 ↗
• 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 ↗
• InjuryFeb 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SUBJECT ICD AND THE TWO (SORIN) ASSOCIATED LEADS WERE IMPLANTED ON (B)(6) 2017. REPORTEDLY, THE DEFIBRILLATION SYSTEM WAS EXPLANTED ON (B)(6) 2018 DUE TO AN INFECTION. PRELIMINARY ANALYSIS REVEALED THAT THE ICD HAS BEEN STERILIZED AND RELEASED ACCORDING TO ALL APPLICABLE PROCEDURES.

  Patient problems: Unspecified Infection

  MAUDE report 7291695 ↗
• 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 ↗
• 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 ↗
• InjuryJun 30, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  DURING A ROUTINE FOLLOW-UP OF A PLATINIUM DR 1510 SN (B)(4) ON (B)(6) 2017, WARNING MESSAGE ¿62 EXCESSIVE CHARGE TIME DETECTED. DEFIBRILLATION SYSTEM POTENTIALLY INEFFECTIVE.¿ WAS DISPLAYED AT INTERROGATION. REPORTER WANTS TO KNOW WHY THIS MESSAGE WAS DISPLAYED AND WHAT THIS INDICATED. THE LAST CHARGE TIME DISPLAYED ON THE OVERVIEW SCREEN WAS 9.8 SECONDS. NO DETECTION LISTED FOR THIS DEVICE. THE LAST CHARGE TO 42 J WAS LISTED AS BEING ON THE DAY OF IMPLANT, (B)(6) 2017. A REAL TIME CHARGE TIME TEST TO 42 JOULES WITH A CHARGE TIME OF 10 SECONDS AND DURATION OF 16 SECONDS WAS CONDUCTED. THIS CHARGE TIME TEST APPEARED TO BE NORMAL. ALL OTHER FOLLOW-UP TESTS WERE NORMAL FOR THIS DEVICE. PRELIMINARY ANALYSIS SHOWED THAT THE REPORTED WARNING WAS DISPLAYED DUE TO AN INCOMPLETE CHARGE THAT OCCURRED BEFORE IMPLANTATION, WHEREAS THE WHOLE SYSTEM WAS PROBABLY NOT IN PLACE. CHARGE TIME UPON IMPLANTATION WAS CORRECT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6680486 ↗
• InjuryFeb 9, 2017Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  ON (B)(6) 2017, EPISODES WITH OVERSENSING AND QUESTIONABLE SHOCK THERAPY DELIVERY WERE REPORTED. REVIEW OF THE EPISODES STORED IN THE DEVICE MEMORY REPORTEDLY REVEALED THE LIKELIHOOD FOR AV CROSSTALK (A ACTIVITY SENSED ON V CHANNEL). THERE WAS SUSPECTED COMPLICATIONS WITH THE POSITION OF BOTH LEADS. AN ANALYSIS IS REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6315351 ↗

Other Microport Crm Srl products

• Reply2 models · 34 reports