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

Model Number SC-2218-50

Device Problems Unexpected Therapeutic Results (1631); Migration (4003)

Patient Problems Hypersensitivity/Allergic reaction (1907); Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Pain (1994); Discomfort (2330); Inadequate Pain Relief (2388); Insufficient Information (4580)

Event Date 04/29/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2218500, model:sc-2218-50, serial: (b)(4), batch: 7093421.Product family: scs-ipg-r-mri, upn: m365sc12160, model: sc-1216, serial: (b)(4), batch: 503865.

Event Description

It was reported that the patient was experiencing severe pain and inadequate stimulation.It was also noted that the patients lead had migrated.The patient were prescribed with steroids combination of tylenol.

Event Description

It was reported that the patient was experiencing severe pain and inadequate stimulation.It was also noted that the patients lead had migrated.The patient were prescribed with steroids combination of tylenol.Additional information was received that the patient underwent revision procedure wherein the leads were repositioned into normal position since it moved lateral.

• Brand Name: LINEAR ST
• 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: 12540848
• MDR Text Key: 273592184
• Report Number: 3006630150-2021-05451
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767725
• UDI-Public: 08714729767725
• 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: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/07/2023
• Device Model Number: SC-2218-50
• Device Catalogue Number: SC-2218-50
• Device Lot Number: 7093272
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR