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

Model Number SC-1200

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

Patient Problems Bacterial Infection (1735); Staphylococcus Aureus (2058); No Code Available (3191)

Event Date 12/26/2019

Event Type  Injury  

Manufacturer Narrative

Model number/catalog number: sc-2218-50, serial number: (b)(4), batch/lot number: 7071034/ 7071086, model/catalog description: linear st lead kit 50 cm.The explanted devices were not returned to bsn as they were discarded by the medical facility.It is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint devices could not be completed.A review of the device history records will be conducted.If there are any further relevant information from that review, a supplemental med watch will be filed.

Event Description

A report was received that the patient had an infection at the battery site was tracking on the leads.The physician believed that the infection was not device related.The patient underwent an explant procedure and antibiotics were prescribed.

• Brand Name: PRECISION MONTAGE 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; cashel road; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 9589528
• MDR Text Key: 175005773
• Report Number: 3006630150-2019-07966
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729905943
• UDI-Public: 08714729905943
• 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: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/02/2021
• Device Model Number: SC-1200
• Device Catalogue Number: SC-1200
• Device Lot Number: 364760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2019
• 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: 72 YR