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

Model Number DB-1140

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Bacterial Infection (1735); Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model#: nm-3138-55, serial#: ni, description: 55cm 8 contact extension kit.Model#: db-4600c, lot#: ni, description: suretek burr hole cover kit.

Event Description

A report was received that the patient developed an infection around the ipg site.The patients ipg and extension were explanted.A ct scan also showed the lead had migrated.It was suspected that the slider holding the lead may have been damaged or not properly fixed at the time of the implant.The patient was administered antibiotics for the infection and will undergo a revision procedure of the lead and burr hole cover once the infection has cleared.

Manufacturer Narrative

Should have stated; additional suspect medical device components involved in the event: model#: nm-3138-55 serial#: ni description: 55cm 8 contact extension kit.Only adverse event should have been checked.Only (b)(4) should have been used field.Date of the event: between (b)(6) 2017 and (b)(6) 2017 additional information was received that the physician confirmed the infection is not device or procedure related and was caused by the patients psoriasis condition.The patient is doing well postoperatively.Additional suspect medical device components involved in the event: model#: nm-3138-55 serial#: (b)(4) description: 55cm 8 contact extension kit the explanted devices were not returned to bsn as they were kept by the medical facility.A review of the manufacturing documentation for the ipg and lead extensions revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.A review of the sterilization documentation for the devices was found to be satisfactory.

Event Description

A report was received that the patient developed an infection around the ipg site as the patient suffers from psoriasis.The patient underwent an ipg and lead extension explant procedure and was administered antibiotics.

• Brand Name: VERCISE PC
• 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: 7178661
• MDR Text Key: 96858354
• Report Number: 3006630150-2018-00083
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: 030017
• 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
• Report Date: 03/09/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/08/2019
• Device Model Number: DB-1140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2017
• Initial Date FDA Received: 01/10/2018
• Supplement Dates Manufacturer Received: 02/12/2018
• Supplement Dates FDA Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2017
• 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): Required Intervention