MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE CARTESIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number DB-2202-45

Device Problems High impedance (1291); Unexpected Therapeutic Results (1631)

Patient Problems Discomfort (2330); Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 12/05/2018

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: model: db-2202-45, serial: (b)(4), description: vercise cartesia.

Event Description

A report was received that the patient's lead had high impedances on 5 contacts.The patient underwent a revision procedure wherein the devices were replaced.The patient is doing well postoperatively and the high impedances have resolved.

Manufacturer Narrative

Additional information was received that the patient experienced pain discomfort and his symptoms of movement disorder returned.Only four lead extensions were returned to bsn.Additional suspect medical device component involved in the event: model: sc-3138-25, serial: (b)(4), description: scs-extension.Model: nm-3138-55, serial: (b)(4), description: dbs-extension.

Event Description

A report was received that the patients lead had high impedances on 5 contacts.The patient underwent a revision procedure where in the devices were replaced.The patient is doing well postoperatively and the high impedances have resolved.

Manufacturer Narrative

Additional information was received that the two leads, which were originally reported as the suspected devices, were not explanted during the revision procedure, they remain implanted.Only three lead extensions were replaced during the revision.A fourth lead extension, which was being implanted, was inadvertently damaged during the revision, and replaced without any allegations against the device.Db-2202-45 sn (b)(4): a review of the manufacturing documentation for the lead revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.Sc-3138-25; sn: (b)(4): lead extension: the complaint of high impedance was confirmed.X-ray inspection of the lead extension revealed fractured cables 1, 5, 6, 7 and 8 were fractured after the weld in the distal connector stack.This type of damage typically occurs when excessive tensile force is exerted onto the lead body and connector section of the lead.Bending the distal end could also cause cable fractures in the connector section of the lead.The broken cables are still contained inside the connector.Sc-3138-25, sn (b)(4): lead extension: the complaint of high impedance was confirmed.X-ray inspection of the lead extension revealed fractured cables 6, 7 and 8 were fractured after the weld in the distal connector stack.This type of damage typically occurs when excessive tensile force is exerted onto the lead body and connector section of the lead.Bending the distal end could also cause cable fractures in the connector section of the lead.The broken cables are still contained inside the connector.Sc-3138-55, sn (b)(4): lead extension: the complaint of high impedance was confirmed.The proximal end of the lead extension was stuck in the associated lead extension connector.The set screw was loose but the lead could not be pulled out.Visual inspection revealed that the proximal contact 8 was crushed by the associated lead extensions setscrew.This type of damage occurs when the setscrew is tightened and the proximal array is not fully inserted into an ipg header or lead extension.If the lead is not fully inserted into the ipg header or lead extension, it results in misalignment of the contacts and high impedance readings.Additionally, the lead body was cleanly cut.The cut damage is a result of a typical explant procedure it is not considered a failure.Sc-3138-55 sn (b)(4): lead extension: this device was damaged while being implanted and there were no allegations against the device.

Event Description

A report was received that the patients lead had high impedances on 5 contacts.The patient underwent a revision procedure wherein the devices were replaced.The patient is doing well postoperatively and the high impedances have resolved.

• Brand Name: VERCISE CARTESIA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 8191673
• MDR Text Key: 131222839
• Report Number: 3006630150-2018-62439
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729905288
• UDI-Public: 08714729905288
• Combination Product (y/n): N
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/30/2018
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 19645911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Date Manufacturer Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR