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

Model Number SC-1132

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Anxiety (2328); Complaint, Ill-Defined (2331); Depression (2361); No Code Available (3191)

Event Date 10/14/2020

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model: sc-2316-50, serial/lot: (b)(4), description: infinion 16 lead kit 50 cm.Model: sc-2316-50, serial/lot: (b)(4), description: infinion 16 lead kit 50 cm.Model: sc-3400-30, serial/lot: (b)(4), description: splitter 2x8 kit-sterile.Model: sc-3400-30, serial/lot: (b)(4), description: splitter 2x8 kit-sterile.

Event Description

It was reported that the patient underwent an explant procedure of the entire scs system due to psychological issues and inadequate stimulation.It was noted that the patient no longer uses the device as she did not think she was getting adequate relief.All explanted products were discarded by the hospital.The patient has fully recovered from the 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 CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 10804494
• MDR Text Key: 215259133
• Report Number: 3006630150-2020-05411
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729821526
• UDI-Public: 08714729821526
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/10/2017
• Device Model Number: SC-1132
• Device Catalogue Number: SC-1132
• Device Lot Number: 18691970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2015
• 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
• Patient Age: 68 YR