MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION LINEAR 3-4; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-2352-70

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Erosion (1750); Therapeutic Effects, Unexpected (2099); No Code Available (3191)

Event Date 11/04/2020

Event Type  Injury  

Manufacturer Narrative

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: (b)(4), model: sc-2352-70, serial: (b)(4), batch: 15852047.Product family: scs-ipg-r, upn: (b)(4), model: sc-1110-02, serial: (b)(4), batch: 15712125.

Event Description

It was reported that the patients stimulation was ineffective and the lead was eroding through the skin.The patient underwent a system explant procedure.The explanted devices were not returned.

• Brand Name: LINEAR 3-4
• 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
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 10883548
• MDR Text Key: 217642360
• Report Number: 3006630150-2020-05743
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729789581
• UDI-Public: 08714729789581
• 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
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2013
• Device Model Number: SC-2352-70
• Device Catalogue Number: SC-2352-70
• Device Lot Number: 15392847
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2012
• 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: 65 YR