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

Model Number SC-1132

Device Problem Power Problem (3010)

Patient Problems Numbness (2415); No Code Available (3191)

Event Date 08/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluation indicated that the ipg passed all tests performed.

Event Description

A report was received that the patient was experiencing slight numbness in the legs.It was also noted that the patient felt stimulation even after using the remote control (rc) to turn it off.The patient underwent an ipg 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 ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; ,; valencia, CA 91355 ; 6619494863
• MDR Report Key: 8644319
• MDR Text Key: 146203890
• Report Number: 3006630150-2019-02490
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/02/2018
• Device Model Number: SC-1132
• Device Catalogue Number: SC-1132
• Device Lot Number: 18934563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2016
• 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: 45 YR