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

Model Number SC-1432

Device Problems Unexpected Therapeutic Results (1631); Wireless Communication Problem (3283)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/03/2021

Event Type  Injury  

Manufacturer Narrative

Exact date unknown, event occurred a few weeks ago from date manufacturer was made aware.

Event Description

It was reported that the patients ipg had difficulty communicating with the remote control.It was also reported that the patient was not getting adequate pain relief.No device malfunction was suspected.The patient underwent a revision procedure wherein the ipg was relocated from the left to the right side.The patient was doing well postoperatively.

• Brand Name: WAVEWRITER ALPHA PRIME
• 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: 15230292
• MDR Text Key: 297946972
• Report Number: 3006630150-2022-04068
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729985075
• UDI-Public: 08714729985075
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/21/2023
• Device Model Number: SC-1432
• Device Catalogue Number: SC-1432
• Device Lot Number: 204128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2021
• 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: 70 YR
• Patient Sex: Female