MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION; DEEP BRAIN STIMULATOR

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

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 11/04/2015

Event Type  Injury  

Manufacturer Narrative

Date of birth: 1957 (exact date is unknown).

Event Description

A report was received that the patient, who is enrolled in the vercise dbs registry clinical study, developed a fistula of the cerebrospinal fluid which was moderate in severity.A compression bandage was applied, medication was administered and the patient recovered and the event resolved.The event was assessed as having a causal relationship to the study procedure and not related to the hardware or stimulation.

Manufacturer Narrative

Additional information was received that because the event was assessed as not related to the device, the device information, model and serial number, is not collected.

Event Description

A report was received that the patient, who is enrolled in the vercise dbs registry clinical study, developed a fistula of the cerebrospinal fluid which was moderate in severity.A compression bandage was applied, medication was administered and the patient recovered and the event resolved.The event was assessed as having a causal relationship to the study procedure and not related to the hardware or stimulation.

Manufacturer Narrative

Additional information was received that a liquid cluster formed at the ipg site.There were no other symptoms.

Event Description

A report was received that the patient, who is enrolled in the vercise dbs registry clinical study, developed a fistula of the cerebrospinal fluid which was moderate in severity.A compression bandage was applied, medication was administered and the patient recovered and the event resolved.The event was assessed as having a causal relationship to the study procedure and not related to the hardware or stimulation.

• 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: 7587022
• MDR Text Key: 110616012
• Report Number: 3006630150-2018-02099
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 09/04/2018

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: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/11/2018
• Supplement Dates Manufacturer Received: 06/21/2018; 08/09/2018
• Supplement Dates FDA Received: 07/12/2018; 09/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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