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

Model Number NM-3138-55

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Fall (1848); Undesired Nerve Stimulation (1980); Inadequate Pain Relief (2388)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: dbs-extension , upn: m365nm3138550, model: nm-3138-55, serial: (b)(4), batch: (b)(4).

Event Description

It was reported that the patient experienced a fall unrelated to the device.The patient experienced trauma to the head, chest, and side of the ribs on the ipg left side.The patient was not receiving adequate pain relief.The patient underwent a revision procedure where the lead extensions were replaced.The patient was noted to be stable post-operatively.

Manufacturer Narrative

Device technical analysis: the returned lead extensions were analyzed and revealed that they were cleanly cut.X-ray inspection of the devices found no cable fractures.The damage is a result of a typical explant procedure, and it is not considered a failure.Labeling review: a product labeling review identified that the devices were used per the instructions for use ifu.There is no evidence the devices were used in a manner inconsistent with the labeled indications.

Event Description

It was reported that the patient experienced a fall unrelated to the device.The patient experienced trauma to the head, chest, and side of the ribs on the ipg left side.The patient was not receiving adequate pain relief.The patient underwent a revision procedure where the lead extensions were replaced.The patient was noted to be stable post-operatively.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 13725927
• MDR Text Key: 287118369
• Report Number: 3006630150-2022-00963
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729820765
• UDI-Public: 08714729820765
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/17/2022
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7082103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention