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

Model Number DB-2201-30DC

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2021

Event Type  Injury  

Manufacturer Narrative

Implant date- between 2017-2018.Additional suspect medical device component involved in the event: product family: dbs-linear leads, upn: (b)(4), model: db-2201-30dc, serial: n/i, lot: n/i.

Event Description

It was reported that the deep brain stimulation patient experienced inadequate stimulation due to a high impedance displayed on one contact of the lead.The patient underwent a lead replacement procedure and had stimulation coverage post-operatively.

Event Description

It was reported that the deep brain stimulation patient experienced inadequate stimulation due to a high impedance displayed on one contact of the lead.The patient underwent a lead replacement procedure and received adequate stimulation coverage post-operatively.

Manufacturer Narrative

Block d6a implant date- between 2017-2018.Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m36db220130dc0, model: db-2201-30dc, serial: (b)(6), lot: 19381027.Returned lead db-2201-30dc sn (b)(6) was analyzed and found that the lead was cleanly cut after the distal end and the distal end was not returned.X-ray inspection found three electrodes were fractured in the proximal array.Typical cable fractures inside the proximal array most likely occur during the explant procedure when being pulled out from the ipg port during the explant procedure.Therefore, this damage is a result of a typical explant procedure and is not considered a failure.Returned lead db-2201-30dc sn (b)(6) was analyzed and found that the lead was cleanly cut after the distal end and the distal end was not returned.The x-ray inspection found three electrodes were fractured eight centimeters from the proximal end at the clik anchor site.Based on all available information, engineers concluded that the loss of stimulation and high impedance measurements were caused by a lead fracture.The lead became bent after exiting the clik x anchor site which exposed the bent location to excessive mechanical, tensile force that caused the lead cables to fracture.

• 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: 11347105
• MDR Text Key: 232506326
• Report Number: 3006630150-2021-00553
• Device Sequence Number: 1
• Product Code: MHY
• 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
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/02/2018
• Device Model Number: DB-2201-30DC
• Device Catalogue Number: DB-2201-30DC
• Device Lot Number: 19535460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention