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

Model Number SC-8416-50

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

Patient Problems Abscess (1690); Unspecified Infection (1930); Fluid Discharge (2686); No Code Available (3191)

Event Date 07/31/2019

Event Type  Injury  

Manufacturer Narrative

The explanted device was not returned to bsn.It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.

Event Description

A report was received that following the previous revision procedure (mfr report no.3006630150-2019-02140) the patients midline incision started to develop signs of infection.Symptoms of redness and oozing drainage were noted and epidural abscess was confirmed through computed tomography (ct) scan.The patient was given antibiotics and underwent an explant procedure.No further information could be obtained.

• Brand Name: ARTISAN MRI
• 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 8952772
• MDR Text Key: 156249280
• Report Number: 3006630150-2019-04625
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729951124
• UDI-Public: 08714729951124
• 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: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/12/2019
• Device Model Number: SC-8416-50
• Device Catalogue Number: SC-8416-50
• Device Lot Number: 20734779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2017
• 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: 68 YR