MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION WAVEWRITER ALPHA 16; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-1216

Device Problems Unexpected Therapeutic Results (1631); Use of Device Problem (1670); Wireless Communication Problem (3283)

Patient Problem Pain (1994)

Event Date 08/02/2023

Event Type  Injury  

Event Description

It was reported that the patient underwent procedures unrelated to the spinal cord stimulator (scs) system during which the implantable pulse generator (ipg) device was turned off.When attempting to turn the stimulation back on the patient received an error message on the remote control and was unable to connect to the ipg, a clinician programmer (cp) was also used however it also could not connect to the ipg, and the patient lost stimulation causing them to experience pain again.The patient underwent a procedure in which the ipg was replaced with a new device, and is doing well post operatively.The ipg will not be returned for analysis as it was retained by the facility.

Event Description

It was reported that the patient underwent procedures unrelated to the spinal cord stimulator (scs) system during which the implantable pulse generator (ipg) device was turned off.When attempting to turn the stimulation back on the patient received an error message on the remote control and was unable to connect to the ipg, a clinician programmer (cp) was also used however it also could not connect to the ipg, and the patient lost stimulation causing them to experience pain again.The patient underwent a procedure in which the ipg was replaced with a new device, and is doing well post operatively.The ipg will not be returned for analysis as it was retained by the facility.It was additionally clarified that the patient underwent somatosensory evoked potential (sep) and motor evoked potential (mep) testing unrelated to the scs system , and not unrelated medical procedures.The local bsc representative requested that the device be returned, but the facility has confirmed that they disposed of the device after the procedure.As a result, the device is not available for return to bsc for laboratory analysis.

• Brand Name: WAVEWRITER ALPHA 16
• 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: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 17840789
• MDR Text Key: 324550076
• Report Number: 3006630150-2023-05902
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729985082
• UDI-Public: 08714729985082
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SC-1216
• Device Catalogue Number: SC-1216
• Device Lot Number: 541939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2022
• 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