MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE GENUS; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number DB-1216

Device Problems High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Discomfort (2330)

Event Date 04/27/2023

Event Type  Injury  

Event Description

It was reported that the patient turned the spinal cord stimulation system on and experienced an uncomfortable shocking sensation throughout her whole body.The sensation dissipated an hour later after she turned the system off.The database analysis noted intermittent high impedances on two occasions, however, the impedances had reverted within the normal range.The patient underwent a revision procedure where upon testing intraoperatively, it was found that the implantable pulse generator (ipg) displayed high impedances.The ipg was explanted and replaced with a new ipg which resolved the issue.The patient was doing well postoperatively.

Event Description

It was reported that the patient turned the spinal cord stimulation system on and experienced an uncomfortable shocking sensation throughout her whole body.The sensation dissipated an hour later after she turned the system off.The database analysis noted intermittent monopolar high impedances on two occasions, however, the impedances had reverted within the normal range.The database also noted there were resets while charging, however, no other charging or battery discharge issues were found.The patient underwent a revision procedure due to the impedances.Upon testing intraoperatively, it was found that the implantable pulse generator (ipg) displayed high impedances.The ipg was explanted and replaced with a new ipg which resolved the issue.The patient was doing well postoperatively.

Manufacturer Narrative

Correction to the initial mdr in field b5.

Manufacturer Narrative

The reported event of high impedances and shocking sensations have been confirmed.The returned ipg was linked to the clinician programmer and high monopolar impedance readings were observed.X-ray inspection of the ipg revealed that the feedthrough case wire was fractured.This high monopolar impedance due to a fractured feedthrough wire can cause intermittent stimulation resulting in compromised stimulation therapy and or shocking sensations.Further investigation found that the fractured wire was likely due to a subpectoral surgical implant technique for the ipg instead of a subcutaneous pocket as instructed by the deep brain stimulation (dbs) systems surgical implant manual.A subpectoral implanted ipg may experience elevated muscle tension forces from cyclical compression between the pectoralis major and the rib cage and may reduce device longevity and induce bending stress on the feedthrough wires.The database analysis 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 turns off and then returns to normal operation within 10-15 seconds.This however, was found to be unrelated to the reported event.A product labeling review did not identify any anomalies and states that implants can fail at any time due to random component failure, loss of battery functionality, or dbs lead breakage, and as such, undesirable sensations and loss of adequate stimulation can occur, all of which are known risks with use of the deep brain stimulation (dbs) system.Additionally, the surgical implant manual instructs to create a pocket for the ipg under the skin in a location that is in the chest or in the abdomen.

Event Description

It was reported that the patient turned the spinal cord stimulation system on and experienced an uncomfortable shocking sensation throughout her whole body.The sensation dissipated an hour later after she turned the system off.The database analysis noted intermittent monopolar high impedances on two occasions, however, the impedances had reverted within the normal range.The database also noted there were resets while charging, however, no other charging or battery discharge issues were found.The patient underwent a revision procedure due to the impedances.Upon testing intraoperatively, it was found that the implantable pulse generator (ipg) displayed high impedances.The ipg was explanted and replaced with a new ipg which resolved the issue.The patient was doing well postoperatively.

• Brand Name: VERCISE GENUS
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 17999682
• MDR Text Key: 326445461
• Report Number: 3006630150-2023-06506
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985044
• UDI-Public: 08714729985044
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/09/2024
• Device Model Number: DB-1216
• Device Catalogue Number: DB-1216
• Device Lot Number: 538373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 10/25/2023; 03/08/2024
• Supplement Dates FDA Received: 10/26/2023; 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 49 KG