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

Model Number SC-1432

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

Patient Problems Seroma (2069); Fluid Discharge (2686)

Event Date 04/03/2021

Event Type  Injury  

Manufacturer Narrative

Approximated based on the date the manufacturer became aware of the event.Additional suspect medical device component involved in the event: product family: scs-paddle leads, upn: (b)(4), model: sc-8352-50, serial: (b)(4), batch: 2000023583.

Event Description

It was reported that the patient went to the emergency room due to having lots of clear fluid coming out of the ipg site.A computerized tomography (ct) scan was taken and revealed copious amounts of fluid in the ipg pocket site.The patient was administered with intravenous (iv) antibiotics and was recommended by the er physician to stay in the hospital overnight however, the patient refused to stay.The patient underwent a spinal cord stimulator (scs) system explant procedure and was still in the hospital receiving iv antibiotics.

• 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: 11720298
• MDR Text Key: 247206237
• Report Number: 3006630150-2021-01759
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729985075
• UDI-Public: 08714729985075
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 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: 12/09/2022
• Device Model Number: SC-1432
• Device Catalogue Number: SC-1432
• Device Lot Number: 201876
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2021
• Initial Date FDA Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 72 YR