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 Edema (1820); Pain (1994); No Code Available (3191)

Event Date 09/15/2017

Event Type  Injury  

Event Description

A report was received that the patient was experiencing pain at the ipg site.Symptom was fluid around ipg.The physician was unsure on what causing the event.The patient will undergo an explant procedure.

Manufacturer Narrative

Additional information was received that the patient and physician have decided against explanting the stimulator.No further course of action at this time.

Event Description

A report was received that the patient was experiencing pain at the ipg site.Symptom was fluid around ipg.The physician was unsure on what causing the event.The patient will undergo an explant procedure.

Manufacturer Narrative

Additional information was received that the patient underwent a revision procedure wherein the ipg was relocated.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on (b)(4) 2018 (b)(4) pm ct.The report number is being corrected from: 3006630150-2018-62488 to: 3006630150-2017-04413.

Event Description

A report was received that the patient was experiencing pain at the ipg site.Symptom was fluid around ipg.The physician was unsure on what causing the event.The patient will undergo an explant procedure.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CLONMEL LIMITED; cashel road; ,; clonmel CA ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; ,; valencia, CA 91355 ; 6619494863
• MDR Report Key: 7012216
• MDR Text Key: 91410221
• Report Number: 3006630150-2017-04413
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729821526
• UDI-Public: 08714729821526
• 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,Followup,Followup
• Report Date: 01/25/2019

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: 04/10/2019
• Device Model Number: SC-1132
• Device Catalogue Number: SC-1132
• Device Lot Number: 20510647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 11/08/2017
• Supplement Dates Manufacturer Received: 11/10/2017; 12/05/2018
• Supplement Dates FDA Received: 11/27/2017; 01/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2017
• 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: 49 YR