VERCISE®
Report
- Report Number
- 3006630150-2014-02034
- Event Type
- Injury
- Date Received
- September 8, 2014
- Date of Event
- August 12, 2014
- Report Date
- August 14, 2014
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- 030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
EXPIRATION DATE: NI.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD COMPUTED TOMOGRAPHY (CT) SCAN WHILE HE WAS IN THE EMERGENCY ROOM (ER) WHICH SHOWED MILD EDEMA INVOLVING THE RIGHT DBS AND WAS TREATED WITH INTRAVENOUS DEXAMETHASONE AND CLOSE MONITORING WAS DONE. LEFT SIDED WEAKNESS WAS NOTED THAT WAS ATTRIBUTED TO THE FOREIGN BODY REACTION SURROUNDING THE RIGHT LEAD WHICH WAS RESOLVED IN TWO DAYS. UPON FOLLOW UP, THE EDEMA HAS SIGNIFICANTLY WORSENED AND SPREAD TO THE OTHER SIDE WITH HYPO ATTENUATION SURROUNDING BILATERAL LEADS. NO ABNORMAL ENHANCEMENT OR ABSCESS WAS NOTED BEFORE THE SYSTEM WAS EXPLANTED. THE REPORTED FOREIGN BODY REACTION WAS DIAGNOSED AS CEREBRITIS.
THE SUSPECT MEDICAL DEVICE REPORTED IN THIS MDR FORM FALLS UNDER INVESTIGATIONAL DEVICE EXEMPTION (IDE) AND SHOULD NOT HAVE BEEN REPORTED ON A 3500A MDR FORM.
SHOULD HAVE BEEN: ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD COMPUTED TOMOGRAPHY (CT) SCAN WHILE HE WAS IN THE EMERGENCY ROOM (ER) WHICH SHOWED MILD EDEMA INVOLVING THE RIGHT DBS AND WAS TREATED WITH INTRAVENOUS DEXAMETHASONE AND CLOSE MONITORING WAS DONE. THE CELLULITIS WOUND SHOWED PURULENT FLUID WHEN ASPIRATED. LEFT SIDED WEAKNESS WAS NOTED THAT WAS ATTRIBUTED TO THE FOREIGN BODY REACTION SURROUNDING THE RIGHT LEAD WHICH WAS RESOLVED IN TWO DAYS. UPON FOLLOW UP, THE EDEMA HAS SIGNIFICANTLY WORSENED AND SPREAD TO THE OTHER SIDE WITH HYPO ATTENUATION SURROUNDING BILATERAL LEADS. NO ABNORMAL ENHANCEMENT OR ABSCESS WAS NOTED BEFORE THE SYSTEM WAS EXPLANTED. THE REPORTED FOREIGN BODY REACTION WAS DIAGNOSED AS CEREBRITIS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SEVERE PERI-LEAD EDEMA OF THE RIGHT DBS LEAD WAS RECOVERING/RESOLVING. CEREBRITIS WAS RECOVERED/RESOLVED. THE PATIENT WAS BACK TO HIS NEUROLOGICAL BASELINE. DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL AND PERFORMANCE TESTS PERFORMED. NO COMPLAINT ABOUT THE FUNCTIONALITY OF THE DEVICE WAS REPORTED. A REVIEW OF STERILIZATION RECORDS FOUND THEM TO BE SATISFACTORY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.
A REPORT WAS RECEIVED THAT THE PATIENT HAD A LOCAL CELLULITIS AT THE CRANIAL INCISION AND WAS ADMITTED FOR FOREIGN BODY REACTION WITH MILD EDEMA AROUND THE RIGHT LEAD. THE LOCAL CELLULITIS WAS TREATED WITH ANTIBIOTICS AND MEDICATION WAS PRESCRIBED FOR THE FOREIGN BODY REACTION. AS A PRECAUTION DUE TO A SCALP INFECTION, THE DEVICES WERE EXPLANTED. THE PATIENT WAS DISCHARGED. THE LOCAL CELLULITIS WAS RELATED TO THE SURGICAL PROCEDURE. THE FOREIGN BODY REACTION WAS RELATED TO THE PROCEDURE AND STUDY DEVICE HARDWARE. THE EVENT WAS NOT RECOVERED/NOT RESOLVED.
A REPORT WAS RECEIVED THAT THE PATIENT WAS ADMITTED FOR A FOREIGN BODY REACTION. MEDICATION WAS PRESCRIBED. THE PATIENT WAS DISCHARGED. THE EVENT WAS NOT RECOVERED/NOT RESOLVED. THE EVENT WAS RELATED TO THE PROCEDURE AND STUDY DEVICE HARDWARE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.
A REPORT WAS RECEIVED THAT THE PATIENT HAD A LOCAL CELLULITIS AT THE CRANIAL INCISION AND WAS ADMITTED FOR FOREIGN BODY REACTION WITH MILD EDEMA AROUND THE RIGHT LEAD. THE LOCAL CELLULITIS WAS TREATED WITH ANTIBIOTICS AND MEDICATION WAS PRESCRIBED FOR THE FOREIGN BODY REACTION. AS A PRECAUTION DUE TO A SCALP INFECTION, THE DEVICES WERE EXPLANTED. THE PATIENT WAS DISCHARGED. THE LOCAL CELLULITIS WAS RELATED TO THE SURGICAL PROCEDURE. THE FOREIGN BODY REACTION WAS RELATED TO THE PROCEDURE AND STUDY DEVICE HARDWARE. THE EVENT WAS NOT RECOVERED/NOT RESOLVED.
A REPORT WAS RECEIVED THAT THE PATIENT WAS ADMITTED FOR A FOREIGN BODY REACTION. MEDICATION WAS PRESCRIBED. THE PATIENT WAS DISCHARGED. THE EVENT WAS NOT RECOVERED/NOT RESOLVED. THE EVENT WAS RELATED TO THE PROCEDURE AND STUDY DEVICE HARDWARE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 549682 | VERCISE® | DEEP BRAIN STIMULATOR | LGW | BOSTON SCIENTIFIC NEUROMODULATION | DB-1110C | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |