MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-4254

Device Problems Use of Device Problem (1670); Structural Problem (2506)

Patient Problem Injury (2348)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: scs-surg acc, upn: (b)(4), model : sc-4254, serial : n/a, lot: 24397747.

Event Description

It was reported that during a deep brain stimulator implant procedure, the physician experienced difficulty using the tunneling tools when trying to implant the lead extension.The physician used two different tunneling tools which both bent and damaged the silicone on the tools.The physician then had to make an additional incision in the middle of the patients neck to pass the tunneling tool to the chest in which the lead extension was successfully implanted.The patient is doing well post-operatively.The devices will not be returned as they were disposed of by the medical facility.

• Brand Name: NA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 11038606
• MDR Text Key: 222370069
• Report Number: 3006630150-2020-06272
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729762751
• UDI-Public: 08714729762751
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/13/2021
• Device Model Number: SC-4254
• Device Catalogue Number: SC-4254
• Device Lot Number: 24397806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2019
• 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
• Patient Weight: 32