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

Model Number SC-1110-02

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

Patient Problems Stroke/CVA (1770); No Code Available (3191)

Event Date 06/01/2019

Event Type  Injury  

Manufacturer Narrative

Explant date: 2019 (month and date are unknown).Additional suspect medical device components involved: model #: sc-8216-70, serial #: (b)(4), description: artisan lead 70 cm.

Event Description

It was reported that the patent had their scs system explanted 1 year ago due to a stroke and the need for an mri.The patient's pain has improved since the stroke.It is unknown if the device caused the stroke or not.No further information can be obtained.

Manufacturer Narrative

Update to fields h6 for result and conclusion codes.H6 patient code 3191: no code available was used because there is not an equivalent fda code for surgical intervention.

Event Description

It was reported that the patent had their scs system explanted 1 year ago due to a stroke and the need for an mri.The patient's pain has improved since the stroke.It is unknown if the device caused the stroke or not.No further information can be obtained.

• Brand Name: PRECISION
• 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: 10295080
• MDR Text Key: 199463965
• Report Number: 3006630150-2020-02993
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767688
• UDI-Public: 08714729767688
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2014
• Device Model Number: SC-1110-02
• Device Catalogue Number: SC-1110-02
• Device Lot Number: 15118554
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 68 YR