ReplyRecalls & reported problems across all models
Microport Crm Srl · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 34
- Deaths reported
- 3
- Injuries reported
- 14
- Recalls
- 0
We found 2 models of Reply by Microport Crm Srl in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between May 12, 2017 and May 20, 2021 — classified as 3 deaths, 14 injuries, 17 malfunctions.
The most frequently reported specific device problem is “Incorrect Device Or Component Shipped” (12 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. 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
Most reported Reply problems
Device problems
- Adverse Event Without Identified Device or Use Problem14
- Incorrect Device Or Component Shipped12
- Nonstandard Device4
- Contamination /Decontamination Problem3
- Output Problem2
- Data Problem1
- Electrical /Electronic Property Problem1
- Failure to Capture1
Patient problems
- No Known Impact Or Consequence To Patient14
- Unspecified Infection9
- No Information5
- Death3
- Pocket Erosion1
- Sepsis1
- Syncope1
Reply models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
Recent Reply adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REPORTEDLY, THE PACING SYSTEM WAS EXPLANTED AND REPLACED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 11856408 ↗InjuryDec 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REPORTEDLY, THE PACING SYSTEM WAS EXPLANTED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10933932 ↗InjuryNov 17, 2020Failure to Capture; Program or Algorithm Execution Problem; Program or Algorithm Execution Failure; Failure to Capture; Program or Algorithm Execution Problem; Program or Algorithm Execution Failure
REPORTEDLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2020 DUE TO A SYNCOPE. UPON DEVICE INTERROGATION, LOSS OF CAPTURE WAS OBSERVED IN SEVERAL EPISODES RECORDED IN THE DEVICE MEMORY. THE PHYSICIAN DECIDED TO PROGRAM THE AUTOMATIC VENTRICULAR THRESHOLD FEATURE. ABSENCE OF VENTRICULAR CAPTURE WITH AN OUTPUT AT 4 V WAS OBSERVED DURING THE CALIBRATION PHASE, ALTHOUGH THE VENTRICULAR CAPTURE THRESHOLD WAS MEASURED AT 0.75 V ¿ 1 V/0.5 MS MANUALLY. IT WAS REPORTED THAT A RECENT FALL COULD HAVE DAMAGED THE VENTRICULAR LEAD, THOUGH IT COULD NOT BE CONFIRMED ON THE X-RAY OR BY REVIEWING THE LEAD IMPEDANCE CURVE. ADDITIONALLY, LOSS OF CAPTURE COULD NOT BE REPRODUCED DURING THE FOLLOW-UP. IT WAS ONLY OBSERVED IN SPECIFIC POSTURAL CONDITIONS. IT WAS DECIDED TO REPLACE THE VENTRICULAR LEAD. PRELIMINARY ANALYSIS REVEALED THAT THE VENTRICULAR AUTO-THRESHOLD FAILED BECAUSE CALIBRATION PHASE CRITERIA WERE NOT MET.
Patient problems: Syncope
MAUDE report 10852990 ↗InjuryOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REPORTEDLY, ON (B)(6) 2020, EROSION OF THE PACING SYSTEM WAS OBSERVED. THE PACING SYSTEM WAS EXPLANTED ON (B)(6) 2020.
Patient problems: Pocket Erosion
MAUDE report 10654418 ↗InjuryOct 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REPORTEDLY, THE PACING SYSTEM WAS REPLACED DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10626365 ↗InjuryApr 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REPORTEDLY, THE SUBJECT PACEMAKER WAS EXPLANTED DUE TO INFECTION. PRELIMINARY ANALYSIS REVEALED THAT THE SUBJECT DEVICE HAS BEEN STERILIZED AND RELEASED ACCORDING TO ALL APPLICABLE PROCEDURES.
Patient problems: Unspecified Infection
MAUDE report 10008571 ↗InjuryDec 24, 2019Premature Discharge of Battery; Premature Discharge of Battery
REPORTEDLY, BATTERY DEPLETION OCCURRED EARLIER THAN EXPECTED. THE DEVICE SHOULD BE RETURNED FOR ANALYSIS. PRELIMINARY ANALYSIS RESULTS SHOWED THAT BASED ON AVAILABLE DATA, NORMAL BATTERY DEPLETION OCCURRED BASED ON HRS GUIDELINES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9516069 ↗MalfunctionDec 14, 2018Data Problem; Data Problem
THE SUBJECT PACEMAKER WAS IMPLANTED ON (B)(6) 2017. REPORTEDLY, DURING A FOLLOW-UP PERFORMED ON SEPTEMBER 2017, THE ESTIMATED RESIDUAL LONGEVITY WAS 12 YEARS. THE ESTIMATED RESIDUAL LONGEVITY WAS SUPERIOR TO 8 YEARS IN MAY 2018 AND SUPERIOR TO 7 YEARS ON (B)(6) 2018. THE PATIENT WAS CONCERNED THAT THIS WAS NOT NORMAL BATTERY DEPLETION. IT WAS ALSO OBSERVED THAT THE PERCENTAGE OF VENTRICULAR PACING OF THE PATIENT WAS INITIALLY LOW (ABOUT 1%) AND INCREASED UP TO 96 - 98 % AFTER AN ATRIOVENTRICULAR NODE ABLATION. PRELIMINARY ANALYSIS REVEALED THAT NORMAL BATTERY DEPLETION OCCURRED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8163570 ↗MalfunctionAug 9, 2018Output Problem; Output Problem
REPORTEDLY, THE SUBJECT PACEMAKER WAS RETURNED FROM THE CUSTOMER, WHO DID NOT WANT TO KEEP IT IN CONSIGNMENT BECAUSE IT WAS IN UNIPOLAR CONFIGURATION.
Patient problems: No Information
MAUDE report 7766713 ↗MalfunctionAug 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REPORTEDLY, THE SUBJECT DEVICE WAS IMPLANTED ON (B)(6) 2018 AFTER IT PASSED THE USE-BY-DATE ((B)(6) 2018). PRELIMINARY ANALYSIS DID NOT REVEAL ANY TECHNICAL AND SAFETY ISSUE.
Patient problems: No Information
MAUDE report 7762174 ↗MalfunctionJul 18, 2018Output Problem; Output Problem
IT WAS REPORTEDLY IMPOSSIBLE TO PROGRAM THE DEVICE OUT OF UNIPOLAR PACING AND SENSING MODE. THE REPORTER AT THE HOSPITAL WAS UNSURE IF THE DEVICE WAS PROGRAMMED TO UNIPOLAR BY THE HOSPITAL STAFF OR IF IT WAS RECEIVED IN UNIPOLAR.
Patient problems: No Information
MAUDE report 7697539 ↗InjuryJul 16, 2018Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem
REPORTEDLY, THE SUBJECT DEVICE WAS REMOVED ON (B)(6) 2018 DUE TO POCKET EROSION. PRELIMINARY ANALYSIS REVEALED THAT THE DEVICE HAS BEEN STERILIZED AND RELEASED ACCORDING TO ALL APPLICABLE PROCEDURES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7689371 ↗MalfunctionJun 22, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
REPORTEDLY, ATRIAL AND VENTRICULAR LEAD IMPEDANCE MEASUREMENTS WERE OUT OF RANGE (HIGH) FOR THE PERIOD: (B)(6) 2018 TO (B)(6) 2018 (33 DAYS). PATIENT STATES THAT WAS NOT IN CONTACT WITH ANY EMI SOURCES AND DID NOT UNDERGO TO ANY MEDICAL PROCEDURES. OTHER LEAD IMPEDANCE MEASUREMENTS WERE IN NORMAL RANGE.
Patient problems: No Information
MAUDE report 7629454 ↗MalfunctionJun 15, 2018Nonstandard Device; Incorrect Device Or Component Shipped; Nonstandard Device; Incorrect Device Or Component Shipped
REPORTEDLY, ON 8 MAY 2018, (B)(4) WAS INFORMED THAT THE AS-SHIPPED POLARITIES OF THE SUBJECT PACEMAKER WERE UNIPOLAR INSTEAD OF BIPOLAR. AS REPLY PACEMAKERS ARE DESIGNED TO PREVENT POLARITY REPROGRAMMING FROM UNIPOLAR TO BIPOLAR WITHOUT NORMAL LEAD IMPEDANCE MEASUREMENT, THE POLARITY CANNOT BE REPROGRAMMED BEFORE IMPLANTATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7604500 ↗MalfunctionJun 15, 2018Nonstandard Device; Incorrect Device Or Component Shipped; Nonstandard Device; Incorrect Device Or Component Shipped
REPORTEDLY, ON (B)(6) 2018, USA CRM TECHNICAL SERVICES WAS INFORMED THAT THE AS-SHIPPED POLARITIES OF THE SUBJECT PACEMAKER WERE UNIPOLAR INSTEAD OF BIPOLAR. AS REPLY PACEMAKERS ARE DESIGNED TO PREVENT POLARITY REPROGRAMMING FROM UNIPOLAR TO BIPOLAR WITHOUT NORMAL LEAD IMPEDANCE MEASUREMENT, THE POLARITY CANNOT BE REPROGRAMMED BEFORE IMPLANTATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7604493 ↗
Other Microport Crm Srl products
All Microport Crm Srl devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
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