VERCISE CARTESIA
Report
- Report Number
- 3006630150-2024-07478
- Event Type
- Injury
- Date Received
- November 1, 2024
- Date of Event
- October 16, 2024
- Report Date
- January 28, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- MHY
- UDI-DI
- 08714729905271
- PMA / PMN Number
- P150031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE - NHL.
ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE - NHL.
ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE - NHL.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT ENROLLED IN CLINICAL STUDY (B)(6) DEVELOPED BILATERAL DEHISCENCE WOUNDS AT THE SITE OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE WOUNDS WERE CLEANED, AND MEDICATION WAS ADMINISTERED. THE EVENT WAS RESOLVING. THIS NON SERIOUS ADVERSE EVENT WAS REPORTED AS RELATED TO THE PROCEDURE AND NOT RELATED TO THE HARDWARE OR STIMULATION.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT ENROLLED IN CLINICAL STUDY A4010 DEVELOPED BILATERAL DEHISCENCE WOUNDS AT THE SITE OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE WOUNDS WERE CLEANED, AND MEDICATION WAS ADMINISTERED. THE EVENT WAS RESOLVING. THIS NON SERIOUS ADVERSE EVENT WAS REPORTED AS RELATED TO THE PROCEDURE AND NOT RELATED TO THE HARDWARE OR STIMULATION. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE WOUND DEHISCENCE WAS LOCATED AT THE SITE OF THE LEAD NOT THE IPG. ADDITIONAL INFORMATION WAS RECEIVED PROVIDING THE MODEL AND SERIAL NUMBER OF THE LEAD.
IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT ENROLLED IN CLINICAL STUDY A4010 DEVELOPED BILATERAL DEHISCENCE WOUNDS AT THE SITE OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE WOUNDS WERE CLEANED, AND MEDICATION WAS ADMINISTERED. THE EVENT WAS RESOLVING. THIS NON SERIOUS ADVERSE EVENT WAS REPORTED AS RELATED TO THE PROCEDURE AND NOT RELATED TO THE HARDWARE OR STIMULATION. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE WOUND DEHISCENCE WAS LOCATED AT THE SITE OF THE LEAD NOT THE IPG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2188497 | VERCISE CARTESIA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | DB-2202-30 | 7085558 | 08714729905271 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |