TYRX™ NMRM6122 (UDI 00763000101626)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000101626), received between Nov 27, 2018 and Sep 26, 2019 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (1 report).

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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST A IMPLANTABLE NEUROLOGICAL STIMULATOR (INS) IMPLANT THE PATIENT DEVELOPED EXTREME IRRITATION AND REDNESS, AROUND THE INS POCKET SITE. THE PATIENT WAS PRESCRIBED ANTIBIOTIC TREATMENT FOR A POTENTIAL INFECTION. IT WAS INDICTED THAT A ANTIBACTERIAL ABSORBABLE ENVELOPE WAS UTILIZED WITH THE INS DEVICE AT IMPLANT. THE DEVICE AND ENVELOPE REMAIN IMPLANTED AND IN USE AND IT WAS NOTED THE PATIENT RECOVERED POST THE ANTIBIOTIC TREATMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9124824 ↗
• InjurySep 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST A IMPLANTABLE NEUROLOGICAL STIMULATOR (INS) CHANGEOUT PROCEDURE THE PATIENT DEVELOPED REDNESS AROUND THE INS POCKET SITE ALONG WITH CELLULITIS. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND ANTIBIOTIC TREATMENT WAS STARTED FOR A POSSIBLE INFECTION. IT WAS INDICTED THAT A ANTIBACTERIAL ABSORBABLE ENVELOPE WAS IMPLANTED WITH THE INS DEVICE AT THE CHANGEOUT PROCEDURE. THE DEVICE AND ENVELOPE REMAIN IMPLANTED AND IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cellulitis; Unspecified Infection

  MAUDE report 9124706 ↗
• MalfunctionAug 7, 2019Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT A ANTIBACTERIAL ABSORBABLE ENVELOPE WAS IMPLANTED ONE DAY PAST THE INDICATED USE BEFORE DATE (UBD). THE PHYSICIAN HAS CHOSEN TO KEEP THE ANTIBACTERIAL ABSORBABLE ENVELOPE IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8870246 ↗
• InjuryJul 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO DAYS POST IMPLANT THE PATIENT REPORTED PAIN AT THE IMPLANT SITE OF THEIR GASTROENTEROLOGY/UROLOGY IMPLANTABLE PULSE GENERATOR (IPG). IT WAS DETERMINED THAT THE PATIENT HAD DEVELOPED AN INFECTION WHEN A ANTIBACTERIAL ABSORBABLE ENVELOPE HAD BEEN IMPLANTED WITH THE IPG SYSTEM. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND THE ANTIBACTERIAL ABSORBABLE ENVELOPE AND IPG SYSTEM REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 8848542 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TEN WEEKS POST IMPLANT THE PATIENT HAD BEEN FEELING PAIN, AND PRESENTED WITH OPEN SORES/WOUNDS NEAR THE SITE OF THEIR GASTRO-URINARY IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM. CULTURES FOR BACTERIAL VIRAL AND GRAM STAIN WERE SENT FOR EVALUATION AND BOTH HAVE RETURNED NEGATIVE AT THIS TIME. IT WAS INDICATED THAT A CONSULT FROM A PHYSICIAN STATED THE PATIENT COULD POSSIBLY HAVE HAD A "POSSIBLE REACTION TO THE TITANIUM OF THE BATTERY." IT WAS NOTED THAT THE PATIENTS ONE MONTH FOLLOW UP SHOWED NO ISSUES. THE DEVICE SYSTEM HAD BEEN IMPLANTED WITH A ANTIBACTERIAL ABSORBABLE ENVELOPE AND IT WAS THOUGHT THAT IT COULD HAVE POSSIBLY BEEN PROTECTING THE PATIENT FROM THE REACTION UNTIL THE ANTIBACTERIAL ABSORBABLE ENVELOPE STARTED TO ABSORB. THE IPG SYSTEM WAS EXTRACTED DUE TO A POSSIBLE INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 8552335 ↗
• InjuryApr 23, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER A RECENT PAIN STIM IMPLANTABLE PULSE GENERATOR (IPG) CHANGEOUT THE PATIENT HAD DEVELOPED A RASH AROUND THE IMPLANT SITES. IT WAS NOTED THAT ANTIBACTERIAL ABSORBABLE ENVELOPES WERE UTILIZED WITH THE IMPLANTS. AN INTERVENTION PROCEDURE WAS COMPLETED TO REMOVE THE ANTIBACTERIAL ABSORBABLE ENVELOPES AND THE PATIENTS RASH CLEARED/WENT AWAY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Rash

  MAUDE report 8539780 ↗
• InjuryApr 23, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AFTER A RECENT PAIN STIM IMPLANTABLE PULSE GENERATOR (IPG) CHANGEOUT THE PATIENT HAD DEVELOPED A RASH AROUND THE IMPLANT SITES. IT WAS NOTED THAT ANTIBACTERIAL ABSORBABLE ENVELOPES WERE UTILIZED WITH THE IMPLANTS. AN INTERVENTION PROCEDURE WAS COMPLETED TO REMOVE THE ANTIBACTERIAL ABSORBABLE ENVELOPES AND THE PATIENTS RASH CLEARED/WENT AWAY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Rash

  MAUDE report 8539731 ↗
• InjuryNov 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED WHEN THE PATIENT RETURNED FOR EVACUATION OF THE HEMATOMA AND A POCKET REVISION, CULTURES WERE TAKEN AND AN INFECTION WAS LATER CONFIRMED. THE PATIENT RECEIVED ANTIBIOTICS AND IT WAS NOTED THE POCKET WAS HEALING.

  Patient problems: Hematoma; Unspecified Infection; Wound Dehiscence

  MAUDE report 8116677 ↗
• MalfunctionNov 27, 2018Impedance Problem; Appropriate Device Problem Term/Code Not Available; Impedance Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A SYSTEM IMPLANT, IMPEDANCE MEASUREMENTS WERE UNABLE TO BE READ WHILE THE ANTIBACTERIAL ABSORBABLE ENVELOPE (AAE) WAS IN USE. THE PHYSICIAN DECIDED TO NOT USE THE (AAE) AND IMPEDANCE MEASUREMENTS WERE CLEARLY DEFINED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8107348 ↗