MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION SPECTRA WAVEWRITER; SPINAL CORD STIMULATOR

Model Number SC-1160

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

Patient Problems Abscess (1690); Bacterial Infection (1735); Cellulitis (1768); Purulent Discharge (1812); Fever (1858); Pain (1994)

Event Date 05/10/2018

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model#: sc-8336-70, serial #: (b)(4), description: coveredge, 32, 70 cm 4x8 surgical lead model#: sc-4316, lot#: 17801468, description: next generation anchor kit-sterile.

Event Description

A report was received that the patient had cellulitis and abscess at the ipg site.Symptoms were fever, pain, and mild purulent drainage coming out of the ipg site which had failed to respond to oral and intravenous antibiotics.The physician performed irrigation and debridement to the infected wound.The patient will undergo an explant procedure.

Manufacturer Narrative

Correction to the initial mdr in fields.Should have been: (b)(6) 2018 additional information was received that the patient underwent an explant procedure.The explanted devices were not returned to bsn.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 device(s) was found to be satisfactory.

Event Description

A report was received that the patient had cellulitis and abscess at the ipg site.Symptoms were fever, pain, and mild purulent drainage coming out of the ipg site which had failed to respond to oral and intravenous antibiotics.The physician performed irrigation and debridement to the infected wound.The patient will undergo an explant procedure.

• Brand Name: SPECTRA WAVEWRITER
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 7615725
• MDR Text Key: 111550954
• Report Number: 3006630150-2018-02170
• 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: 030017
• 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,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/18/2019
• Device Model Number: SC-1160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2017
• 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: 55 YR