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

Model Number DB-2202-45

Device Problems High impedance (1291); Low impedance (2285); Migration (4003)

Patient Problem No Code Available (3191)

Event Date 02/27/2019

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-extension, upn: (b)(4), model: nm-3138-55, (b)(4).Product family: dbs-linear leads, upn: (b)(4), model: db-2202-45, (b)(4).Product family: dbs-extensio, upn: (b)(4), model: nm-3138-55, (b)(4).

Event Description

A report was received that the patient underwent a lead and lead extension replacement procedure.The physician noted migration in one of the leads and elected to replace it.There were high impedances on the left lead and low impedances on the right lead.The lead extensions were suspected to be the cause and were both replaced.

Event Description

A report was received that the patient underwent a lead and lead extension replacement procedure.The physician noted migration in one of the leads and elected to replace it.There were high impedances on the left lead and low impedances on the right lead, the lead extensions were suspected to be the cause and were both replaced.

Manufacturer Narrative

Db-2202-45 (b)(4): the complaint of high impedance has been confirmed.X-ray of the lead revealed fractured cable 1 and 2 within the proximal array.No cables are exposed at the fracture site.This damage typically occurs when the lead body is subjected to excessive tensile force or when the lead extension connector is bent with the lead proximal end inserted in it.Nm-3138-55 (b)(4): the complaints of high impedance have been confirmed.Visual inspection of the lead revealed that the proximal end was fractured between contacts 2 and 3.The lead failed impedance tests at contact 1 as stated in the reported complaint.No cables are exposed at the fracture site.X-ray inspection confirmed broken cables in the proximal end of the lead.This damage typically occurs when the proximal array is bent resulting to cable fractures within the contacts.

Event Description

A report was received that the patient underwent a lead and lead extension replacement procedure.The physician noted migration in one of the leads and elected to replace it.There were high impedances on the left lead and low impedances on the right lead, the lead extensions were suspected to be the cause and were both replaced.

Manufacturer Narrative

Additional information was received that the patient is doing well post operatively.Db-2202-45 - (b)(4).The returned device was analyzed and no anomalies were found.Db-2202-45 - (b)(4).The complaint of high impedance has been confirmed.X ray of the lead revealed that the proximal end was opened between contact 1 and 2.No cables are exposed at the fracture site.This damage typically occurs when the lead body is subjected to excessive tensile force or when proximal array is bent resulting to cable fractures within the connector.Nm-3138-55 -(b)(4).The complaints of high impedance have been confirmed.Visual inspection of the lead revealed that the proximal end was fractured between contacts 2 and 3.The lead failed impedance tests at contact 1 as stated in the reported complaint.No cables are exposed at the fracture site.X-ray inspection confirmed broken cables in the proximal end of the lead.This damage typically occurs when the lead body is subjected to excessive tensile force or when proximal array is bent resulting to cable fractures within the connector.Nm-3138-55 - (b)(4).The returned device was analyzed and no anomalies were found.

• Brand Name: VERCISE CARTESIA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 8429200
• MDR Text Key: 139091270
• Report Number: 3006630150-2019-01112
• Device Sequence Number: 1
• Product Code: NHL
• 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: 05/07/2019

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: 06/21/2020
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 5068433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 03/18/2019
• Supplement Dates Manufacturer Received: 04/14/2019; 05/02/2019
• Supplement Dates FDA Received: 04/30/2019; 05/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention