Wearable Antenna Assembly PDBT-915-2KRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00818225020150), received between Jun 10, 2020 and Sep 24, 2026 — classified as 1 death, 28 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (4 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, 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Solder Joint Fracture

  The patient reported a shocking sensation from their Transmitter Assembly. The patient was provided a replacement Transmitter Assembly and the shocking sensations were resolved.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50885794 ↗
• InjuryMar 25, 2025Detachment of Device or Device Component; Power Problem; Detachment of Device or Device Component; Power Problem

  THE PATIENT REPORTED THEIR TRANSMITTER ASSEMBLY WAS OVERHEATING AND CAUSED A BURNING SENSATION TO THE SKIN. HOWEVER, THE PATIENT DID NOT EXPERIENCE ANY DAMAGE TO THE SKIN OR REQUIRE MEDICAL INTERVENTION.

  Patient problems: Burning Sensation

  MAUDE report 21691056 ↗
• InjuryMar 25, 2025Use of Device Problem; Use of Device Problem

  THE PATIENT REPORTED THEY HAVE NOT HAD PAIN RELIEF SINCE THE DEVICE WAS IMPLANTED. ADDITIONALLY, THE PATIENT REPORTED THEY HAVE NOT USED THE DEVICE FOR AN EXTENDED AMOUNT OF TIME DUE TO POTENTIAL OVERSTIMULATION. THE COMMERCIAL TEAM MEMBER CONFIRMED ALL COMPONENTS SEEMED TO BE WORKING PROPERLY AND THE PROGRAMS ON THE TRANSMITTER ASSEMBLY WERE CHANGED. THE PATIENT WAS ENCOURAGED TO TRY THE NEW SETTINGS AND FOLLOW-UP WITH ANY ISSUES. AS OF (B)(6) 2025, THE PATIENT IS UTILIZING THERAPY AND HAS NOT HAD ANY FURTHER COMPLAINTS SINCE RESUMING THERAPY.

  Patient problems: Electric Shock

  MAUDE report 21687734 ↗
• InjuryMay 24, 2024Use of Device Problem; Detachment of Device or Device Component; Manufacturing, Packaging or Shipping Problem; Use of Device Problem; Detachment of Device or Device Component; Manufacturing, Packaging or Shipping Problem

  THE PATIENT REPORTED THEIR TRANSMITTER ASSEMBLY WAS GETTING HOT AND CAUSED A BURNING SENSATION TO THE SKIN. THE OVERHEATING DID NOT CAUSE TISSUE DAMAGE OR REQUIRE MEDICAL INTERVENTION. THE PATIENT WAS PROVIDED A REPLACEMENT TRANSMITTER ASSEMBLY.

  Patient problems: Burning Sensation

  MAUDE report 19390351 ↗
• InjuryMay 20, 2024Battery Problem; Battery Problem

  THE PATIENT REPORTED THEIR TRANSMITTER ASSEMBLY WAS GETTING HOT AND CAUSED A BURNING SENSATION TO THE SKIN. THE OVERHEATING DID NOT CAUSE TISSUE DAMAGE OR REQUIRE MEDICAL INTERVENTION. THE PATIENT WAS PROVIDED A REPLACEMENT TRANSMITTER ASSEMBLY.

  Patient problems: Burning Sensation

  MAUDE report 19354974 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED INCREASED PAIN AND REQUESTED PROGRAMMING. ON (B)(6) 2023, THE CLINICAL REPRESENTATIVE MET WITH THE PATIENT TO COMPLETE A REPROGRAMMING SESSION. AFTER THE REPROGRAMMING, THE PATIENT REPORTED SIGNIFICANT IMPROVEMENT IN THERAPY AND THE CLINICAL REPRESENTATIVE EDUCATED THE PATIENT ON HOW TO WEAR THE ANTENNA CORRECTLY.

  Patient problems: Pain

  MAUDE report 18179329 ↗
• InjuryNov 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED FEELING A JOLTING SENSATION FROM THE TRANSMITTER BUT NOT THE ANTENNA. THE PATIENT IS USING THEIR OTHER TRANSMITTER ASSEMBLY (SET AT THE SAME PARAMETERS) WITH NO COMPLAINTS. NO ADDITIONAL ADVERSE EVENTS OR COMPLICATIONS HAVE BEEN REPORTED AND THE PATIENT CONTINUES TO HAVE 80% RELIEF. ADDITIONALLY, THE PATIENT WAS PROVIDED A REPLACEMENT TRANSMITTER ASSEMBLY.

  Patient problems: Electric Shock

  MAUDE report 18057882 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THEIR WEARABLE ANTENNA ASSEMBLY WAS OVERHEATING AND BURNED A HOLE IN HER NYLON NIGHTGOWN. THE OVERHEATING DID NOT CAUSE TISSUE DAMAGE OR REQUIRE MEDICAL INTERVENTION. THE PATIENT WAS PROVIDED A REPLACEMENT WAA.

  Patient problems: Burning Sensation

  MAUDE report 17021675 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THEIR WEARABLE ANTENNA ASSEMBLY WAS OVERHEATING AND CAUSING A BURNING SENSATION TO THE SKIN. THE OVERHEATING DID NOT CAUSE TISSUE DAMAGE OR REQUIRE MEDICAL INTERVENTION. THE PATIENT WAS PROVIDED A REPLACEMENT WAA.

  Patient problems: Burning Sensation

  MAUDE report 17021113 ↗
• InjuryMay 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED BURN MARKS ON THEIR SKIN AS THEY PLACED THE ANTENNA DIRECTLY ON THEIR SKIN. THE PATIENT REPORTED THE WAA DID NOT OVERHEAT AND THEY WERE RECEIVING PAIN RELIEF. THE WOUNDS HAVE HEALED, THE PATIENT WILL WEAR THE DEVICE AGAIN, AND PLACE SOMETHING BETWEEN THE ANTENNA AND THE SKIN.

  Patient problems: Burn(s)

  MAUDE report 16979884 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED PERIODIC SHOCKING SENSATION DURING USE OF THE TRANSMITTER. THEY RECEIVED ADEQUATE THERAPY WITH NO SHOCKING WITH THEIR OTHER TRIAL TRANSMITTER ON THE SAME PROGRAMMING PARAMETERS. THE LEADS WERE PULLED ON (B)(6) 2023 AT THE END OF THEIR TRIAL PERIOD AND NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Electric Shock

  MAUDE report 16762862 ↗
• InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THEIR WEARABLE ANTENNA ASSEMBLY WAS OVERHEATING AND CAUSING A BURNING SENSATION TO THE SKIN. THE OVERHEATING DID NOT CAUSE TISSUE DAMAGE OR REQUIRE MEDICAL INTERVENTION. THE PATIENT WAS PROVIDED A REPLACEMENT WAA.

  Patient problems: Burning Sensation

  MAUDE report 16638934 ↗
• InjuryMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THEIR WEARABLE ANTENNA ASSEMBLY WAS OVERHEATING AND CAUSING A BURNING SENSATION TO THE SKIN. ADDITIONALLY, THE PATIENT REPORTED THE WAA DID NOT ALWAYS TURN ON AFTER A FULL CHARGE. THE OVERHEATING DID NOT CAUSE TISSUE DAMAGE OR REQUIRE MEDICAL INTERVENTION. THE PATIENT WAS PROVIDED A REPLACEMENT WAA.

  Patient problems: Burning Sensation

  MAUDE report 16625255 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THEIR WEARABLE ANTENNA ASSEMBLY WAS OVERHEATING AND CAUSING A BURNING SENSATION TO THE SKIN. THE OVERHEATING DID NOT CAUSE TISSUE DAMAGE OR REQUIRE MEDICAL INTERVENTION. THE PATIENT WAS PROVIDED A REPLACEMENT WAA.

  Patient problems: Burning Sensation

  MAUDE report 15673638 ↗
• InjuryOct 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THEIR WEARABLE ANTENNA ASSEMBLY WAS OVERHEATING AND CAUSING A BURNING SENSATION TO THE SKIN. THE OVERHEATING DID NOT CAUSE TISSUE DAMAGE OR REQUIRE MEDICAL INTERVENTION. THE PATIENT WAS PROVIDED A REPLACEMENT WAA.

  Patient problems: Burning Sensation

  MAUDE report 15543127 ↗
• InjurySep 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THEIR WEARABLE ANTENNA ASSEMBLY WAS OVERHEATING AND CAUSING A BURNING SENSATION TO THE SKIN. THE OVERHEATING DID NOT CAUSE TISSUE DAMAGE OR REQUIRE MEDICAL INTERVENTION. THE PATIENT WAS PROVIDED A REPLACEMENT WAA.

  Patient problems: Burning Sensation

  MAUDE report 15452317 ↗
• InjurySep 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THEIR WEARABLE ANTENNA ASSEMBLY WAS OVERHEATING AND CAUSING A BURNING SENSATION TO THE SKIN. THE OVERHEATING DID NOT CAUSE TISSUE DAMAGE OR REQUIRE MEDICAL INTERVENTION. THE PATIENT WAS PROVIDED A REPLACEMENT WAA.

  Patient problems: Burning Sensation

  MAUDE report 15451278 ↗
• InjuryAug 16, 2022Temperature Problem

  THE PATIENT REPORTED THEIR WEARABLE ANTENNA ASSEMBLY WAS OVERHEATING AND CAUSING A BURNING SENSATION TO THE SKIN. THE OVERHEATING DID NOT CAUSE TISSUE DAMAGE OR REQUIRE MEDICAL INTERVENTION.

  Patient problems: Burning Sensation

  MAUDE report 15236757 ↗
• InjuryAug 9, 2022Overheating of Device

  THE PATIENT REPORTED THEIR WEARABLE ANTENNA ASSEMBLY WAS GETTING HOT AND CAUSING A BURNING SENSATION TO THE SKIN. THE OVERHEATING DID NOT CAUSE TISSUE DAMAGE OR REQUIRE MEDICAL INTERVENTION.

  Patient problems: Burning Sensation

  MAUDE report 15191567 ↗
• InjuryMay 24, 2022Temperature Problem

  THE PATIENT WAS IMPLANTED WITH A STIMQ NEUROSTIMULATOR ON (B)(6) 2019. ON (B)(6) 2022 THE PATIENT REPORTED A BURNING SENSATION IN THEIR LOWER BACK AROUND THE SITE OF THE STIMULATOR. AFTER MEETING WITH THE CLINICAL REPRESENTATIVE, THE PATIENT CLARIFIED THAT THEY WERE FEELING A HOT SENSATION AND SOMETHING WAS BURNING THEIR SKIN. THE PATIENT WAS IMMEDIATELY INSTRUCTED TO STOP WEARING THE WEARABLE ANTENNA ASSEMBLY AND TURN IT OFF. THE ANTENNA PAD WAS GETTING HOT REGARDLESS OF INCREASING OR DECREASING THE POWER INDEX. THE PATIENT PRESENTED WITH A LARGE RED/IRRITATED AREA TO THEIR LOWER BACK DIRECTLY OVER THE STIMWAVE STIMULATOR RECEIVER, SPANNING FROM MIDLINE BACK TO THE LATERAL COIL POCKET. THE PATIENT ALSO HAS A NEVRO SCS SYSTEM IMPLANTED WITH THE IPG ON HIS RIGHT LOWER BACK JUST BELOW THE REPORTED RED AREA. THE STIMWAVE DEVICE REMAINS IMPLANTED, THE PATIENT WAS PROVIDED NEW WAAS AND WAS INSTRUCTED TO WEAR THE ANTENNA SUPERIOR TO THE NEVRO BATTERY TO AVOID ANY HEATING/BURNING OF THE SKIN. THE PATIENT IS RECEIVING THERAPY, THE SKIN HAS CLEARED SUBSTANTIALLY, AND THEY ARE DOING WELL.

  Patient problems: Burning Sensation; Skin Inflammation/ Irritation

  MAUDE report 14491349 ↗
• InjuryMar 2, 2022Overheating of Device

  THE PATIENT STATED THEIR WEARABLE ANTENNA ASSEMBLY IS HOT TO THE TOUCH AFTER USE AND MEASURED THE EXTERNAL TEMPERATURE TO BE 102° F USING AN INFRARED LASER THERMOMETER.

  Patient problems: Burning Sensation

  MAUDE report 13655811 ↗
• MalfunctionJan 11, 2022Temperature Problem

  THE PATIENT REPORTED THEIR WEARABLE ANTENNA ASSEMBLY GETS HOT AFTER TURNED ON CAUSING A BURNING SENSATION TO THE SKIN.

  Patient problems: Burning Sensation

  MAUDE report 13218792 ↗
• MalfunctionDec 8, 2021Overheating of Device; Peeled/Delaminated

  THE PATIENT REPORTED THEIR WEARABLE ANTENNA ASSEMBLY GETS HOT AND THE OUTSIDE IS PEELING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12963610 ↗
• DeathNov 12, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT DIED OF NATURAL CAUSES ON (B)(6) 2021. THERE WERE NO ISSUES REPORTED WITH THE STIMWAVE PRODUCTS. THE PATIENT'S WIFE WOULD LIKE TO RETURN BOTH WEARABLE ANTENNA ASSEMBLY UNITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12804838 ↗
• InjurySep 18, 2021Inappropriate/Inadequate Shock/Stimulation

  THE PATIENT REPORTED UNINTENDED STIMULATION WHILE WEARING THE WEARABLE ANTENNA ASSEMBLY.

  Patient problems: Electric Shock

  MAUDE report 12493397 ↗