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 Wound Dehiscence (1154); Hematoma (1884); Unspecified Infection (1930); Staphylococcus Aureus (2058); No Code Available (3191)

Event Date 07/27/2020

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-extension, upn: (b)(4), model: nm-3138-55, serial: (b)(4), batch: 7052176.Product family: dbs-ipg-pc, upn: (b)(4), model: db-1140-s, serial: (b)(4), batch: 630428.

Event Description

It was reported that the patient went to the er, emergency room, because the lead extension was exposed behind his left ear.Bacitracin and sterile gauze were placed over the wound and the patient was sent home with bacitracin and keflex for several days and referred to follow up with dr.(b)(6).A week later, dr.(b)(6) did an exploratory surgery procedure and flushed out the wound.The wound was found to be infected, so he decided to explant the two lead extensions and the ipg.

Event Description

It was reported that the patient went to the er, emergency room, because the lead extension was exposed behind his left ear.Bacitracin and sterile gauze were placed over the wound and the patient was sent home with bacitracin and keflex for several days and referred to follow up with dr.Ponce.A week later, dr.Ponce did an exploratory surgery procedure and flushed out the wound.The wound was found to be infected, so he decided to explant the two lead extensions and the ipg.Additional information was received that the cause of the infection was a bump to the head that required drainage of a hematoma which progressed to the lead extension being exposed.The patient was placed on antibiotics.The devices were disposed of 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
• MDR Report Key: 10463585
• MDR Text Key: 204680985
• Report Number: 3006630150-2020-03738
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/18/2021
• Device Model Number: NM-3138-55
• Device Catalogue Number: NM-3138-55
• Device Lot Number: 7052089
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR