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

Model Number SC-1160

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

Patient Problems Irritation (1941); Pain (1994); Discomfort (2330); Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

Approximated based on the date the manufacturer became aware of the event.

Event Description

It was reported that the patient was experiencing a lot of pain after the ipg implant procedure.It was also reported that the pain was actually in her rectum and felt like razor blades.The patient was given pain medications and steroids for her discomfort that physician believed was from nerve irritation possibly from the anterior attempt.Patient was successfully reprogrammed which was a complete resolution for the nerve pain and irritation.The patient was happy with the results of the device.

• 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: 11055947
• MDR Text Key: 223153050
• Report Number: 3006630150-2020-06334
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729951254
• UDI-Public: 08714729951254
• Combination Product (y/n): N
• 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: 12/22/2020

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: 10/02/2022
• Device Model Number: SC-1160
• Device Catalogue Number: SC-1160
• Device Lot Number: 374296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2020
• 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: 54 YR