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

Model Number SC-1132

Device Problems Material Separation (1562); Material Protrusion/Extrusion (2979)

Patient Problems Bacterial Infection (1735); Purulent Discharge (1812)

Event Date 08/20/2015

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model #: sc-2218-70, serial #: (b)(4), description: linear st lead, 70cm; model #: sc-4316, lot #: 17665946, description: next generation anchor kit-sterile.Sc-1132 (sn (b)(4)): device evaluation indicated that the device passed all tests performed.Visual inspection of the device found no anomalies.Residual gas analysis verified that the device insulation was not compromised.Review of the sterilization record did not find any anomalies or deviations that potentially relate to the reported event.Sc-2218-70 (sn (b)(4)): device evaluation indicated that the lead bodies were cut during the explant procedure.Review of the sterilization record did not find any anomalies or deviations that potentially relate to the reported event.Sc-4316 (lot# 17665946): device evaluation indicated that one of the clik anchors had two missing silicon eyelets; the other one had one missing silicon eyelet.Review of the sterilization record did not find any anomalies or deviations that potentially relate to the reported event.

Event Description

A report was received that the patient had a staphylococcal infection.The patient underwent an explant procedure.

Manufacturer Narrative

Additional information was received that the symptom of infection included pus coming out from the lead, incision, and middle of the back, and lead protrusion.The physician did not specify whether the event was device or procedure related.Antibiotics were prescribed.With regard to the missing eyelets, the physician confirmed that the eyelets were not left in the patient's body.

Event Description

A report was received that the patient had a staphylococcal infection.The patient underwent an explant procedure.

• Brand Name: PRECISION SPECTRA®
• 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: 5167349
• MDR Text Key: 28900738
• Report Number: 3006630150-2015-02729
• Device Sequence Number: 1
• Product Code: LGW
• 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: 08/20/2015

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: 01/31/2017
• Device Model Number: SC-1132
• Other Device ID Number: M365SC11320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2015
• Initial Date FDA Received: 10/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2015
• 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