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

Model Number SC-1160

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

Patient Problems Bacterial Infection (1735); Purulent Discharge (1812); Seroma (2069); Discomfort (2330); No Code Available (3191)

Event Date 05/31/2019

Event Type  Injury  

Manufacturer Narrative

Model number/catalog number: sc-2218-50, serial number: (b)(4), batch/lot number: 5127845 / 5127850, model/catalog description: linear st lead kit 50 cm.A review of the manufacturing documentation for the devices revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.A review of the sterilization documentation for the devices were found to be satisfactory.

Event Description

A report was received that following an implant procedure, the patient was experiencing itchiness at the ipg site.It was noted that there was redness, tenderness and pus coming out of the ipg site.A serosanguineous fluid was drained from the site and the patient was prescribed antibiotics.The patient was advised that the ipg and the leads may need to be removed if there was a complication of infection.

• Brand Name: SPECTRA WAVEWRITER
• 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 CLONMEL LIMITED; cashel road; ,; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; ,; valencia, CA 91355 ; 6619494863
• MDR Report Key: 8787362
• MDR Text Key: 150950813
• Report Number: 3006630150-2019-03511
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729951254
• UDI-Public: 08714729951254
• 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: 07/12/2019

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: 04/01/2021
• Device Model Number: SC-1160
• Device Catalogue Number: SC-1160
• Device Lot Number: 353114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 07/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2019
• 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: 58 YR