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

Model Number NM-3138-55

Device Problem Fracture (1260)

Patient Problems Inadequate Pain Relief (2388); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/01/2020

Event Type  Injury  

Manufacturer Narrative

Exact date unknown, event occurred in (b)(6) 2020.(b)(4).Additional suspect medical device components involved in the event: product family: dbs-extension, upn: m365nm3138550, model: nm-3138-55, serial: (b)(4), batch: 7024993.

Event Description

It was reported the patient experienced a worsening of symptoms likened to her pre-implant state.Reprogramming was attempted with no effect.X-ray imaging showed the extensions were completely disconnected.It was assessed that the extensions broke due to extensive traction causing there to be no stimulation therapy.Patient underwent a revision procedure to replace the extensions and has fully recovered.

Manufacturer Narrative

With the available information, boston scientific concludes that the reported fractures were due to the lead extension connectors separating from the lead bodies which were most likely caused by excessive mechanical force.A review of the manufacturing documentation for lead extensions nm-3138-55, serial numbers (b)(6) and (b)(6) revealed that no anomalies or deviations related to the event occurred during manufacturing.The lead extensions were not returned to boston scientific for analysis.However, review of the provided x-ray image in-situ and a photo post-explant of the lead extensions revealed that both devices were fractured and the lead extension connectors were completely separated from the lead body.It appears the damage was a result of excessive mechanical force exerted into the lead extension body and connector; therefore, the most probable cause has been traced to component failure.

Event Description

It was reported the patient experienced a worsening of symptoms likened to her pre-implant state.Reprogramming was attempted with no effect.X-ray imaging showed the lead extensions were completely disconnected.The physician assessed that the lead extensions broke due to extensive traction causing there to be no stimulation therapy.The patient underwent a revision procedure to replace the lead extensions and has fully recovered.

• Brand Name: NA
• 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: 11175485
• MDR Text Key: 226993502
• Report Number: 3006630150-2021-00026
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729820765
• UDI-Public: 08714729820765
• 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: 04/14/2021

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: 07/04/2020
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7025252
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/12/2021
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 03/22/2021
• Supplement Dates FDA Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR