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

Model Number NM-3138-55

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Erosion (1750); Impaired Healing (2378); Fluid Discharge (2686)

Event Date 06/30/2022

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 just over three months post explant of the implantable pulse generator (ipg) the patient reported to the physician that the explant incision site had not healed, despite having been placed on three rounds of oral antibiotics and two picc lines.The patient stated that he pulled something out of the incision site.The patient underwent a revision procedure in which the lead extensions would be explanted, however during the prep for the procedure when the patients right side of the head was shaved the physician observed two pustules behind his ear.The physician assessed that the previous infection had tracked up the lead extensions.When removing the second lead extension the physician noted that it could not be disconnected from the lead and that the wires were exposed, because the patient had pulled out the sheath covering.He also stated that the patient pulled on the lead extension with so much force that he distorted the lead between the retention sleeve and the most proximal contact.The patient will undergo future procedure to explant the remaining devices.The explanted lead extensions will not be returned for analysis as they were discarded by the facility.

• 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: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 15718243
• MDR Text Key: 302917473
• Report Number: 3006630150-2022-05919
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 08714729820765
• UDI-Public: 08714729820765
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/15/2023
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7088543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• 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