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

Model Number SC-1160

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Pain (1994); Scar Tissue (2060); Inadequate Pain Relief (2388); Numbness (2415); Insufficient Information (4580)

Event Date 04/08/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: exact date unknown, event occurred after a separate lead replacement procedure on (b)(6) 2021.Additional suspect medical device components involved in the event: product family: scs- linear leads, upn: m365sc2218700, model: sc-2218-70, serial: (b)(4), batch: (b)(4).

Event Description

It was reported that the patient was not getting the desired result after implant procedure, and postoperative programming was not successful.The patient was only getting stimulation in the ribs and arms or hands.The patient had an x-ray and showed the leads were still in the proper location when compared to the surgical x-ray.The physician mentioned possibility of scar tissue from previous implant or unknown disease process as possible explanation to poor response to therapy.The patient was also experiencing a numb sensation from elbow to the pinky finger on both arms that began immediately after surgery, which was improved slightly.There was no medical treatment for the numbness which the doctor does not relate to the stimulator.The physician does not have an explanation for the numbness.The patient underwent an explant procedure wherein all components were explanted and discarded.

• Brand Name: SPECTRA WAVEWRITER
• 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; cashel road; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12188719
• MDR Text Key: 262197939
• Report Number: 3006630150-2021-03873
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729951254
• UDI-Public: 08714729951254
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/02/2022
• Device Model Number: SC-1160
• Device Catalogue Number: SC-1160
• Device Lot Number: 376883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2020
• 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
• Patient Age: 53 YR