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

Model Number SC-1160

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Therapeutic Results (1631)

Patient Problems Muscle Weakness (1967); Undesired Nerve Stimulation (1980); Pain (1994); Inadequate Pain Relief (2388); Numbness (2415)

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

Exact date unknown, event occurred several days ago from the date the manufacturer was made aware.

Event Description

It was reported that the patient experienced inadequate stimulation, pain, unwanted sensation, and shocking sensations around the ipg site.It was noted that the unwanted sensations occurred even when the device was off.Patients entire right leg is constantly numb with pins and needles feeling from above the right knee to the foot.The patient underwent an ipg replacement procedure and was doing well postoperatively.The explanted ipg will not be returned per hospital policy.

• 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: 15524811
• MDR Text Key: 301002378
• Report Number: 3006630150-2022-05163
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/27/2021
• Device Model Number: SC-1160
• Device Catalogue Number: SC-1160
• Device Lot Number: 361950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2019
• 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 Age: 55 YR
• Patient Sex: Female
• Patient Weight: 72 KG