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

Model Number SC-1232

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

Patient Problems Bacterial Infection (1735); Hypersensitivity/Allergic reaction (1907); Seroma (2069); Implant Pain (4561)

Event Date 08/08/2021

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: scs- paddle leads, upn: m365sc8336500, model: sc-8336-50, serial: (b)(4), batch: 7074608.

Event Description

It was reported that the patient was having sudden onset of extreme pain and hypersensitivity at the ipg site.The patient underwent a procedure wherein upon opening of the ipg pocket, it was discovered that there was a cloudy fluid surrounding the ipg, and the ipg was explanted.The midline incision was opened and the lead tails were cut just below the anchor site.The lead tails were then pulled back through the ipg pocket and removed.The paddle portion of the lead was left in the epidural space in hope that the system can be replaced after the suspected infection clears.The patient was placed on antibiotics, and the explanted ipg was discarded.

• 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: 12422168
• MDR Text Key: 269788213
• Report Number: 3006630150-2021-04943
• 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: 09/03/2021

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: 06/15/2023
• Device Model Number: SC-1232
• Device Catalogue Number: SC-1232
• Device Lot Number: 514045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 09/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• 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: 42 YR