Primo MRI™ DR SureScan™ DDMD3D4Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00763000001513), received between Jan 6, 2020 and Sep 8, 2026 — classified as 40 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (19 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. May 10, 2023Class IOpen, Classified

   There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

   Z-1718-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Device Sensing Problem

  It was reported that the Right Ventricular (RV) lead exhibited T-Wave Oversensing (TWOS) resulting in misclassification of Ventricular Fibrillation (VF), High Rate Non-Sustained, and Non-Sustained Ventricular Tachycardia episodes. The Right Atrial (RA) lead also exhibited oversensing resulting in misclassification of Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes. It was also reported that the Implantable Cardioverter Defibrillator (ICD) may have inappropriately classified AT/AF with fast ventricular response as monitored Ventricular Tachycardia (VT) at times. The RV lead, RA lead and ICD remain in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50674200 ↗
• InjuryMar 10, 2026Insufficient Device Problem Information

  FOLLOW UP WITH THE CLINIC INDICATED THAT THERE WERE NO ISSUES WITH THE DEVICE OR LEADS AND NO SHOCKS OR ANTI-TACHYCARDIA PACING (ATP). IT WAS NOTED THAT THE VENTRICULAR TACHYCARDIA (VT) MONITOR ZONE HAD BEEN ENABLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24562541 ↗
• InjuryMar 10, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND INAPPROPRIATE HIGH VOLTAGE THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED AS FAST VENTRICULAR TACHYCARDIA (FVT). IT WAS NOTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL AND STARTED ON INTRAVENOUS (IV) MEDICATION TO ADDRESS THE ISSUE. ALSO, IT WAS NOTED THAT A NEW WAVELET WAS COLLECTED. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24560021 ↗
• InjuryDec 10, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO SHORTNESS OF BREATH AND DIZZINESS. THE PATIENT HAD BEEN OUT OF THEIR MEDICATION FOR MORE THAN SIX MONTHS. AN ELECTROCARDIOGRAM DEMONSTRATED ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. MEDICATION WAS ADMINISTERED WHICH IMPROVED THE PATIENT'S RATE. THE PATIENT WAS ADMITTED. AN INTERROGATION OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE FOLLOWING DAY INDICATED MULTIPLE INAPPROPRIATE HIGH VOLTAGE THERAPIES AND ANTI-TACHYCARDIA PACING (ATP) FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE WITH PREMATURE VENTRICULAR COMPLEXES AND SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT FELL INTO THE VENTRICULAR TACHYCARDIA (VT)/VENTRICULAR FIBRILLATION (VF) ZONE FROM TWO WEEKS PRIOR. THE PATIENT WAS RESTARTED ON THEIR ANTICOAGULANT FOR AF. THE PATIENT LEFT THE HOSPITAL AGAINST MEDICAL ADVICE PRIOR TO A FINAL CARDIOLOGY EVALUATION. THE PATIENT PRESENTED TO THE EMERGENCY ROOM FIVE MONTHS LATER ANOTHER ICD INTERROGATION INDICATED ATP DELIVERY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE PATIENT'S ATRIAL SENSITIVITY WAS ADJUSTED. THE ICD REMAINS IN USE. THE PATIENT IS A PARTICIPAN

  Patient problems: Dizziness; Dyspnea; Shock from Patient Lead(s)

  MAUDE report 23767263 ↗
• InjuryAug 19, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKED FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE WHICH THE DEVICE DETECTED AND TREATED AS VENTRICULAR TACHYCARDIA (VT). THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22841855 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO AN INFECTION NEAR THE DEVICE POCKET. THE PATIENT EXPERIENCED REDNESS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Medical device site infection

  MAUDE report 22497530 ↗
• InjuryOct 30, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND SHOCK FOR A SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODE DETECTED IN THE VENTRICULAR TACHYCARDIA (VT) ZONE. THE ICD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 20566993 ↗
• InjuryOct 29, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSSIBLY DELIVERED INAPPROPRIATE SHOCKS FOR SUPRA VENTRICULAR TACHYCARDIA (SVT). THE ICD DETECTED THE EPISODE AS VENTRICULAR FIBRILLATION (VF). IT WAS ALSO NOTED THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. THE ICD SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 20561432 ↗
• MalfunctionOct 24, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED A HEART RATE LOWER THAN THAT OF THE PROGRAMMED LOWER RATE OF THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 20523073 ↗
• InjuryAug 5, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED SHOCKS FOR DETECTED FAST VENTRICULAR TACHYCARDIA (FVT) THAT WAS POSSIBLY SUPRA VENTRICULAR TACHYCARDIA (SVT). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 19906294 ↗
• MalfunctionMay 1, 2024Data Problem; Data Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DID NOT CLEAR HIGH RATE NON-SUSTAINED EPISODES FROM THE PREVIOUS INTERROGATION. ADDITIONALLY, THE RIGHT ATRIAL (RA) LEAD HAD UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS, BUT DID NOT APPEAR TO IMPACT DEVICE FUNCTION OR PERFORMANCE. THE ICD AND LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220956 ↗
• InjuryApr 23, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY FOR RAPID VENTRICULAR RESPONSE (RVR) THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). THERE WAS AN ATRIAL ARRHYTHMIA IN PROGRESS AT THE TIME OF THE THERAPY.  IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 19163229 ↗
• MalfunctionMar 21, 2024Electromagnetic Interference; High impedance; Over-Sensing; Electromagnetic Interference; High impedance; Over-Sensing

  IT WAS REPORTED THAT A RIGHT VENTRICULAR (RV) LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO HIGH RATE NON-SUSTAINED (HRNS) EPISODES AND SENSING INTEGRITY COUNTER (SIC). THERE WAS POSSIBLE OVERSENSING OBSERVED ON STORED ATRIAL AND VENTRICULAR EPISODES, IN ADDITION TO HIGHER THAN NORMAL ATRIAL AND VENTRICULAR PACING IMPEDANCE MEASUREMENTS. THE CLINICIAN CONFIRMED THAT THE PATIENT WAS IN A SURGICAL PROCEDURE WITH EXTENSIVE CAUTERY BEING USED AT THE TIME OF THE EPISODES. LATER THAT SAME EVENING, THE PATIENT RECEIVED SEVERAL APPROPRIATE HIGH VOLTAGE THERAPIES FOR TRUE VENTRICULAR ARRHYTHMIAS. THERE WAS INTERMITTENT UNDERSENSING NOTED DURING THE ARRHYTHMIAS. SUBSEQUENTLY, THERE WAS A PERSISTENT DROP IN RIGHT ATRIAL (RA) LEAD IMPEDANCE AND P-WAVES. THERE WAS A PERSISTENT DROP IN RV PACING AND RV COIL IMPEDANCE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18952362 ↗
• MalfunctionMar 19, 2024Contamination; Packaging Problem; Contamination; Packaging Problem

  IT WAS REPORTED THAT THERE WAS CONDENSATION INSIDE THE PACKAGING. THE PAPERS INSIDE THE BOX WERE STUCK TOGETHER DUE TO MOISTURE.  THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18933626 ↗
• InjuryNov 18, 2023Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT A REMOTE MONITORING TRANSMISSION INDICATED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITHHELD THERAPY FOR AN EPISODE DETECTED IN THE SINUS TACHYCARDIA ZONE THAT WAS LATER DETERMINED TO BE VENTRICULAR TACHYCARDIA (VT). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 18166861 ↗
• InjuryNov 13, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED A SHOCK FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF) DUE TO THE RATE EXCEEDING THE PROGRAMMED SUPRA VENTRICULAR TACHYCARDIA (SVT) LIMIT. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 18125315 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION WITH THE ORGANISM IDENTIFIED AS STAPHYLOCOCCUS BACTERIA. BOTH LEADS HAD VEGETATION AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 17861961 ↗
• InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE MONTHS POST IMPLANT, THE PATIENT EXPERIENCED AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POCKET INFECTION AND EROSION. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 17729026 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POCKET EROSION AND INFECTION. THE ICD SYSTEM WAS REMOVED, AND THE PATIENT WAS TREATED WITH ANTIBIOTIC THERAPY AND WOUND MANAGEMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 17695172 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD HIGH THRESHOLDS. IT WAS ALSO REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE AN ICD POCKET INFECTION AND THE ICD COMING OUT OF THE PATIENT'S SKIN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 17619350 ↗
• InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL WITH BRADYCARDIA POST IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. A CHECK ON THE DEVICE YIELDED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD LOSS OF CAPTURE ON THE CURRENT ELECTROGRAM. THE LEAD HAD SENSING INTEGRITY COUNTER (SIC) AND ONE HIGH RATE NON-SUSTAINED (HR-NS) EPISODE SHOWING OVERSENSING OF NON-PHYSIOLOGIC SIGNALS ON THE RIGHT ATRIAL (RA) CHANNEL AND RV CHANNEL. FURTHER EVALUATION YIELDED THAT THE RA LEAD AND RV LEAD HAD DISLODGED AND PULLED BACK POST-IMPLANT WITH HIGH THRESHOLDS. THE PHYSICIAN SUSPECTED THAT THE ICD SYSTEM MAY BE INFECTED AT THE IMPLANT SITE AND DECIDED TO REMOVE THE ICD SYSTEM. A NEW ICD SYSTEM WAS IMPLANTED ON THE RIGHT SIDE OF THE PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Unspecified Infection

  MAUDE report 16870227 ↗
• MalfunctionMar 16, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT THAT THEY WERE EXPERIENCING NEW SYMPTOMS THAT THEY HAVE NEVER HAD BEFORE, AND ALLUDED THAT IT MIGHT BE DUE TO THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT REPORTED HAVING DIZZINESS, TINGLING IN THEIR ARM, HEADACHES, AND "OCCASIONAL PINCHING AROUND THE SITE HITTING A SHOULDER NERVE". THE PATIENT WAS REFERRED TO THEIR FOLLOWING PHYSICIAN. A FOLLOW-UP INVESTIGATION REVEALED THAT THE PATIENT HAS NOT HAD A RECENT DEVICE CHECK. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Headache; Paresthesia

  MAUDE report 16554992 ↗
• InjuryFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD ERODED THROUGH THE PATIENT¿S SKIN AND THE PATIENT DEVELOPED AN INFECTION IDENTIFIED AS METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS. THE ICD SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Pocket Erosion

  MAUDE report 16414984 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LESS THAN A MONTH AFTER IMPLANT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 16379668 ↗
• InjuryNov 17, 2022Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER A HEATED ARGUMENT, RECEIVING SHOCKS AND GENERALIZED WEAKNESS. INTERROGATION SHOWED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD DELIVERED ANTI-TACHYCARDIA PACING (ATP) FOR EPISODES OF VENTRICULAR FIBRILLATION (VF) AND ALSO TREATED WITH SHOCKS. IT WAS SUSPECTED THAT THE RHYTHMS MAY HAVE BEEN ATRIAL ARRHYTHMIAS IN PROGRESS WITH RAPID VENTRICULAR RATES, AND IT WAS SUSPECTED THAT THE THERAPIES MAY HAVE BEEN INAPPROPRIATE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 15817507 ↗