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

Model Number SC-1132

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

Patient Problems Bacterial Infection (1735); Fever (1858); Nausea (1970); Chills (2191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2014

Event Type  Injury  

Manufacturer Narrative

Date of event: approximated based on the date the manufacturer became aware of the event.

Event Description

It was reported that the patient underwent an explant procedure due to an unknown reason.

Manufacturer Narrative

Block b3: exact date unknown, event occurred in (b)(6) 2014.D7: explant date: (b)(6) 2014.Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2218500, model: sc-2218-50, serial: (b)(6), batch: 16275036/16275036.

Event Description

It was reported that the patient underwent an explant procedure due to an unknown reason.Additional information was received that the reason for explant was due to a multiple infection that the patient developed at the spinal cord.Patient had fever, chills, and nausea.The physician believed that it was not device or procedure related and the cause was unknown.The patient was placed on antibiotics.All components were explanted and were not returned.

• Brand Name: PRECISION SPECTRA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 11761329
• MDR Text Key: 248544615
• Report Number: 3006630150-2021-01898
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729821526
• UDI-Public: 08714729821526
• Combination Product (y/n): N
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2015
• Device Model Number: SC-1132
• Device Catalogue Number: SC-1132
• Device Lot Number: 16288757
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR