Vercise Genus™ DB-1216Recalls & reported problems

Summary

The FDA's MAUDE database contains 584 adverse event reports that list this exact device (DI 08714729985044), received between Apr 5, 2021 and Sep 30, 2026 — classified as 23 deaths, 428 injuries, 133 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (163 reports).

2 FDA recall records name this device's identifier, 2 still open.

2 other recalls cover devices cleared under the same FDA submission (P150031); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 8, 2025Open, Classified

   Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device removal/replacement and users may experience high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth connectivity challenges.

   Z-2558-2025 · Root cause: Labeling design · FDA record ↗

2. Apr 18, 2024Open, Classified

   Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience undesired sensations, transient worsening of movement disorder symptoms, which may lead patient to request surgical intervention for replacement or revision.

   Z-1890-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 584 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient that is implanted with the Deep Brain Stimulation (DBS) system, developed a bacterial infection at the Implantable Pulse Generator (IPG) site, with multiple symptoms including redness and inflamed skin. The patient underwent an IPG explant procedure, was prescribed antibiotics and is doing well post operatively. Cultures were taken; however, the results were not provided. It is unknown if the infection is device or procedure related. The IPG will not be returned for analysis as it was disposed of per the hospital policy.

  Patient problems: Bacterial Infection; Erythema; Swelling/ Edema

  MAUDE report 50942455 ↗
• InjurySep 29, 2026Charging Problem

  Patient problems: Implant Pain

  MAUDE report 50937754 ↗
• InjurySep 28, 2026Inappropriate/Inadequate Shock/Stimulation; Intermittent Energy Output

  It was reported that the Deep brain stimulation (DBS) patient experienced episodes of intermittent stimulation caused by the Implantable pulse generator (IPG), this was noticed when the patient was lying in bed. The patient indicated that this episode recurred on three more different times, and stimulation resumed immediately. The patient reported a sensation consistent with an increase in stimulation, resulting in a tingling sensation, unsteady walking and a vibrating sensation in the left side; however, at a later date the patient perceived the vibrating sensation on both sides. This situation caused discomfort and muscle/nerve tension, as the patient felt the muscle lock up for a couple of seconds and then release, causing pain in the chest area when it happened. The vibrating sensation evolved into a zapped sensation with a recurrence every 10 to 15 minutes. The patient reports feeling mentally tired as a consequence of this situation. The patient will undergo a revision procedure at a later stage.

  Patient problems: Balance Problems; Chest Pain; Fatigue; Inappropriate Device Stimulation of Tissue; Insufficient Information; Paresthesia

  MAUDE report 50920291 ↗
• DeathSep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the deep brain stimulation (DBS) patient passed away. No further information was able to be obtained regarding the patients death.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876476 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Deep brain stimulation (DBS) patient underwent a system explant procedure due to an infection localized subcutaneously in the neck area that spread to the lead. The patient experienced neck pain. Cultures were taken, indicating the presence of Staphylococcus sp. Per the physician, the infection was not device or procedure related. The devices were retained by the hospital and will not be returned for analysis. The patient was placed on antibiotics therapy, immediately after the explant procedure took place. Postoperatively, the patient was recovering well.

  Patient problems: Bacterial Infection; Neck Pain

  MAUDE report 50869031 ↗
• InjurySep 22, 2026Unexpected Therapeutic Results; Wireless Communication Problem

  It was reported that the patient that is implanted with the Deep Brain Stimulation (DBS) system experienced difficulty charging of the Implantable Pulse Generator (IPG) causing a loss of stimulation, the return of their pre-existing Parkinson's disease symptoms of tremor, rigidity and bradykinesia, and the remote control would not connect to the IPG. The patient was provided with charging education and was able to charge the IPG, got it out of hibernation and was able to reconnect the remote control. The patient stated that they fell a few months ago onto the IPG pocket site, after which the physician examined the IPG pocket site, imaging was performed and no irregularities were identified. The patient underwent an IPG replacement procedure, therapy has been restored and is doing well post operatively.

  Patient problems: Bradycardia; Fall; Shaking/Tremors; Unspecified Musculoskeletal problem

  MAUDE report 50862389 ↗
• DeathSep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with a deep brain stimulation (DBS) system passed away. The cause of death is unknown. No further information has been obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831583 ↗
• DeathSep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Deep brain stimulation (DBS) patient passed away from natural causes. The cause of death is not believed to be device related; however, it remains unconfirmed. The patient had Parkinson's disease, which was considered a comorbidity that could have contributed to the patient's death.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820364 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Insufficient Information

  MAUDE report 50765077 ↗
• DeathSep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the deep brain stimulation (DBS) patient has died for an unknown reason. The patients sister reported that the death was expected and not related to DBS or essential tremor for which the DBS system was indicated. The physician had no information to provide regarding the death.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736519 ↗
• DeathSep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Deep brain stimulation (DBS) patient passed away. The cause of death is not believed to be device related; however, it remains unconfirmed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50736218 ↗
• DeathSep 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with a Deep Brain Stimulation (DBS) system passed away. The cause of death is unknown. Based on the physician's assessment, the death was not considered related to the DBS device or therapy. No recent procedures were reported that may have caused or contributed to the patient's death. The provider was unable to obtain additional information regarding the death; however, the patient's husband reported that the patient passed away in (b)(6) 2025. No autopsy results were available. The provider reported that the patient was severely overweight and experienced chronic shortness of breath; however, it is unknown whether these conditions contributed to the patient's death. No further information has been obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50622700 ↗
• InjuryAug 28, 2026Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem

  It was reported that the deep brain stimulation (DBS) patient experienced a loss of stimulation due to the inability to charge the implantable pulse generator (IPG) after losing the remote control and charger. The patient ended up in the hospital, and it is unknown if the patients hospitalization was related to the device or device stimulation.

  Patient problems: Insufficient Information

  MAUDE report 50488996 ↗
• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50351111 ↗
• InjuryAug 19, 2026Unexpected Therapeutic Results

  It was reported that a Deep Brain Stimulation (DBS) patient experienced an intermittent vibrating sensation in the chest, with episodes lasting from approximately one to several minutes. These events occurred over a period of two consecutive days. Due to concern that the symptoms could be indicative of atrial fibrillation, the patient presented to an Urgent Care facility for evaluation. The DBS stimulation was temporarily deactivated, and an electrocardiogram (EKG) was performed. The EKG findings were normal, and the DBS stimulation was subsequently reactivated. No recurrence of the chest vibration sensation has been reported since that time. Following the event, the patient was doing well and stimulation therapy was unaffected.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50334628 ↗
• InjuryAug 18, 2026Use of Device Problem; Charging Problem

  It was reported that a Deep Brain Stimulation (DBS) patient underwent an Implantable Pulse Generator (IPG) revision after the IPG battery was reported to no longer hold a charge. It was further reported that the patient had previously undergone shoulder surgery during which electrocautery was used and no protective measures were taken to protect the IPG. The physician stated that the IPG was most likely damaged during that procedure. The reported IPG was explanted and replaced with a new IPG. The patient was reported to be receiving therapy following the revision procedure. The location of the explanted device is unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50311691 ↗
• InjuryAug 18, 2026High impedance; Unexpected Therapeutic Results; Migration

  It was reported that, following a mammogram procedure, the deep brain stimulation (DBS) patient experienced loss of stimulation and high impedances across all implantable pulse generator (IPG) contacts, resulting in hospitalization. It was noted that the IPG was forcefully manipulated during a mammogram procedure. In the physicians opinion it is unknown what caused the unintended patient event. The patient was discharged and continues under the care of their physician.

  Patient problems: Insufficient Information

  MAUDE report 50310151 ↗
• DeathAug 13, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with a Deep Brain Stimulation (DBS) system passed away. The cause of death is unknown. Attempts were made to obtain additional information regarding the event, including the cause of death, potential device involvement, recent procedures, autopsy results, and relevant comorbidities. However, the hospital declined to release patient-specific information due to patient privacy requirements. No further information has been obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50230550 ↗
• MalfunctionAug 12, 2026Inappropriate or Unexpected Reset

  It was reported that the Deep brain stimulation (DBS) database analysis performed identified a Bluetooth fault code when charging the implantable pulse generator (IPG). Noise from the charging field of the charger interferes with the Bluetooth communication chipset, thus causing internal resets where the device stimulation momentarily turns off and then returns to normal operation. The IPG remains implanted in the patient and delivering therapy.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50225892 ↗
• InjuryAug 11, 2026Inappropriate/Inadequate Shock/Stimulation

  It was reported that a Deep Brain Stimulation (DBS) patient experienced a sensation described as a sudden rush of weirdness while charging the Implantable Pulse Generator (IPG). The patient did not report any pain associated with the event. The patient stated that a similar sensation had been experienced previously when the physician changed the therapy settings from one stimulation program to another. The database analysis performed identified a Bluetooth fault code when charging the IPG. Noise from the charging field of the charger interferes with the Bluetooth communication chipset, thus causing internal resets where the device stimulation momentarily turns off and then returns to normal operation. No other anomalies were identified during the analysis, and the device charge log was found to be normal. The IPG remains implanted and continues to deliver therapy as intended. It was further reported that a firmware update was performed on the IPG, resolving the Bluetooth fault code associated with charging. Following the update, the patient was able to successfully charge the IPG without interruption and was reported to be doing well.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50216488 ↗
• DeathAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient implanted with a deep brain stimulation (DBS) system passed away. The cause of death is unknown. No further information has been obtained.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50201397 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Deep brain stimulation (DBS) patient reported experiencing intermittent episodes characterized by an inability to initiate movement, accompanied by loss of balance and subsequent falls. During follow-up communication, the patient stated that, following initial device programming, the device had been routinely powered off at night and reactivated in the morning, based on a misunderstanding of the intended usage instructions. The patient was subsequently advised to leave the device activated continuously. The patient further reported multiple episodes of feeling unwell or experiencing an undefined sensation of being "off" immediately preceding a loss of balance. These events reportedly resulted in falls and were followed by significant difficulty recovering, including challenges with independently regaining an upright position. According to the physician, this event is not believed to be related to the device. The reported difficulty with movement was considered consistent with a severe Parkinson's disease off state. Subsequently, the patient presented to the Emergency Room (ER) with stroke-like symptoms after experiencing a fall that resulted in a tailbone f

  Patient problems: Ambulation or Postural Difficulties; Balance Problems; Bone Fracture(s); Facial Paralysis; Fall; Speech Disorder

  MAUDE report 50182562 ↗
• MalfunctionAug 7, 2026Unexpected Therapeutic Results; Intermittent Energy Output

  Patient problems: Anxiety; Cramp(s) /Muscle Spasm(s); Discomfort; Pain; Shaking/Tremors

  MAUDE report 50177270 ↗
• InjuryAug 5, 2026Inappropriate/Inadequate Shock/Stimulation; Unexpected Therapeutic Results; Charging Problem

  It was reported that the Deep Brain Stimulation (DBS) patient was unable to charge the implant beyond two thirds of its capacity and experienced a shocking sensation. No additional adverse patient effects were reported. The device will not be returned to Boston Scientific, as it remains implanted in the patient.

  Patient problems: Ambulation or Postural Difficulties; Cognitive Changes; Inappropriate Device Stimulation of Tissue; Shaking/Tremors

  MAUDE report 50148091 ↗
• InjuryAug 5, 2026Inappropriate/Inadequate Shock/Stimulation

  It was reported that the Deep Brain Stimulation (DBS) patient experienced transient shocking sensations and paresthesia radiating from the right fingertips to the right jaw. According to the patient, the initial episodes occurred on two separate occasions while sitting stationary and watching television. Following these events, the patient met with the sales representative, who performed a full impedance check. All impedance values were found to be within the normal range. Due to the patient's significant cardiac history, including a previous widow-maker heart attack, the patient was referred to a cardiologist for evaluation. The patient was seen by the cardiologist, and no obvious cardiac abnormalities were identified. The patient reported that an electrocardiogram (EKG) was performed and yielded normal results, indicating that the reported symptoms were not cardiac-related. The patient denied charging the device, undergoing any surgical or diagnostic procedures such as Magnetic Resonance Imaging (MRI), or experiencing any injury or fall at the time of the reported events. During a subsequent discussion, the patient reported one additional transient episode of a similar paresthesi

  Patient problems: Inappropriate Device Stimulation of Tissue; Paresthesia

  MAUDE report 50145522 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150031. One submission often covers many models, so check the product and lot details in each record.

• Z-2340-2025 · Jul 8, 2025 · Open, Classified
  Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual
• Z-2125-2020 · Apr 24, 2019 · Terminated
  Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated for use in bilateral stimulation of the