MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION LEAD KIT 30 CM; DEEP BRAIN STIMULATOR

Model Number	DB-2201-30AC
Medical Device Problem Codes	Fracture (1260); High impedance (1291)
Health Effect - Clinical Codes	Bacterial Infection (1735); Inadequate Pain Relief (2388)
Date of Event	04/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model: db-2201-45dc serial/lot: (b)(4).Description: 45 cm twist lead, 0.016 tungsten stylet.
Event or Problem Description
A report was received that the patient was experiencing inadequate therapy due to high impedances.X-ray revealed that the connectors for the left and right lead were situated apart with one behind the right ear and one further down the neck.The physician decided to perform an exploratory surgery to determine the source of the impedance.The left lead connector was reconnected to the lead extension.The physician noticed that the connector further down the neck had a slight discontinuation of the insulation on the lead.The physician could see a fracture of the lead, however there were no exposed cables.The patient will undergo a full lead revision.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model: db-1110c serial/lot: (b)(4) description: vercise implantable pulse generator kit model: nm-3138-55 serial/lot: (b)(4) description: 55 cm 8 contact extension kit model: db-2201-30ac serial/lot: (b)(4) description: vercise lead kit, 30cm additional information was received that the dbs system was explanted due to infection.There was swelling and redness at the incision sites of the previous exploratory surgery.The patient was administered antibiotics.No further information could be obtained.The explanted devices were not returned to bsn as they were discarded.It is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint devices could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.
Event or Problem Description
A report was received that the patient was experiencing inadequate therapy due to high impedances.X-ray revealed that the connectors for the left and right lead were situated apart with one behind the right ear and one further down the neck.The physician decided to perform an exploratory surgery to determine the source of the impedance.The left lead connector was reconnected to the lead extension.The physician noticed that the connector further down the neck had a slight discontinuation of the insulation on the lead.The physician could see a fracture of the lead, however there were no exposed cables.The patient will undergo a full lead revision.
Event or Problem Description
A report was received that the patient was experiencing inadequate therapy due to high impedances.X-ray revealed that the connectors for the left and right lead were situated apart with one behind the right ear and one further down the neck.The physician decided to perform an exploratory surgery to determine the source of the impedance.The left lead connector was reconnected to the lead extension.The physician noticed that the connector further down the neck had a slight discontinuation of the insulation on the lead.The physician could see a fracture of the lead, however there were no exposed cables.The patient will undergo a full lead revision.

• Brand Name: LEAD KIT 30 CM
• Common Device Name: DEEP BRAIN STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 7597216
• Report Number: 3006630150-2018-02136
• Device Sequence Number: 10807785
• Product Code: LGW
• UDI-Device Identifier: 08714729820772
• UDI-Public: 08714729820772
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: 150031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2018

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/13/2016
• Device Model Number: DB-2201-30AC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2018
• Supplement Date Received by Manufacturer: 06/25/2018; 06/25/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 07/11/2018; 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention