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

Model Number NM-3138-55

Device Problem Defective Device (2588)

Patient Problem No Code Available (3191)

Event Date 06/30/2020

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model: nm-3138-55, serial/ lot: (b)(4), description: 55cm 8 contact extension.

Event Description

It was reported that following the implantation of the extensions, one of four was tested and did not function as intended.A revision was performed in which the extension was removed and replaced.The patient has recovered since the procedure.

Event Description

It was reported that following the implantation of the extensions, one of four was tested and did not function as intended.A revision was performed in which the extension was removed and replaced.The patient has recovered since the procedure.

Manufacturer Narrative

The lead nm-3138-55 serial number: (b)(6) was returned and analyzed.The allegations of the lead not functioning as intended have been confirmed.X-ray inspection of the lead extension revealed four cables 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.

• 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: 10317897
• MDR Text Key: 200246515
• Report Number: 3006630150-2020-03062
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/17/2020
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7013093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Date Manufacturer Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention