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

Model Number SC-1232

Device Problem Migration (4003)

Patient Problems Erosion (1750); Fever (1858); Inflammation (1932); Discomfort (2330); Implant Pain (4561); Swelling/ Edema (4577)

Event Date 03/12/2021

Event Type  Injury  

Event Description

It was reported that the patient was experiencing pain at the ipg site with significant tenderness to palpation.Symptoms of redness and swelling were noted and the ipg was not laying down flat and was tenting her skin causing considerable pain.The patient was also experiencing low-grade fever and was started with keflex and has noted improvement of inflammation and no longer had any fevers.The patient underwent a revision procedure wherein a new pocket was created and closed the old pocket site.No device malfunction was suspected and the patient was doing well postoperatively.

• Brand Name: WAVEWRITER ALPHA
• 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: 11720007
• MDR Text Key: 247250245
• Report Number: 3006630150-2021-01758
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729985099
• UDI-Public: 08714729985099
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/23/2021

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: 01/11/2023
• Device Model Number: SC-1232
• Device Catalogue Number: SC-1232
• Device Lot Number: 503590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2021
• Initial Date FDA Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2021
• 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: 46 YR
• Patient Weight: 64