MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE GEVIA IPG KIT; DEEP BRAIN STIMULATOR

Model Number DB-1200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Hematoma (1884); Swelling (2091)

Event Date 05/06/2018

Event Type  Injury  

Manufacturer Narrative

The explanted devices were not returned to bsn.The lead extension is not expected to be returned.The model and serial number of the device is not known, therefore a device history review cannot be performed.It is indicated that the ipg will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the manufacturing documentation for the ipg revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.A review of the sterilization documentation for the device was found to be satisfactory.

Event Description

A report was received that the patient was admitted do to an infected hematoma at the site of the ipg which was moderate in severity.The patient underwent an explant of the ipg and the extensions, was treated with medication and was then discharged.The patient and event were assessed as not recovered and not resolved.The event was assessed as having a probable relationship to the study procedure and hardware and not related to the simulation.

Event Description

A report was received that the patient was admitted do to an infected hematoma at the site of the ipg which was moderate in severity.The patient underwent an explant of the ipg and the extensions, was treated with medication and was then discharged.The patient and event were assessed as not recovered and not resolved.The event was assessed as having a probable relationship to the study procedure and hardware and not related to the simulation.

Manufacturer Narrative

Additional information was received that the patient had reddening and swelling at the ipg pocket site.The reddening followed the line of the electrode up to her throat.Per laboratory findings no abnormalities were indicated and the patient did not have a fever.The patient was treated with antibiotics following the explant.Per the clinical study protocol, no additional information is available regarding the additional suspect devices or the event.

Event Description

A report was received that the patient was admitted do to an infected hematoma at the site of the ipg which was moderate in severity.The patient underwent an explant of the ipg and the extensions, was treated with medication and was then discharged.The patient and event were assessed as not recovered and not resolved.The event was assessed as having a probable relationship to the study procedure and hardware and not related to the simulation.

• Brand Name: VERCISE GEVIA IPG KIT
• Type of Device: DEEP BRAIN STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 7551524
• MDR Text Key: 109479993
• Report Number: 3006630150-2018-01920
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: 150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/19/2018

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/27/2019
• Device Model Number: DB-1200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 05/10/2018; 06/13/2018
• Supplement Dates FDA Received: 05/29/2018; 06/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 57 YR