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

Model Number	SC-2158-50
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device component involved in the event: product family: scs-linear leads, upn: (b)(4), model: sc-2158-50, serial: (b)(4), batch: 16613516.
Event or Problem Description
It was reported that the patient was experiencing inadequate stimulation.The patient underwent an explant procedure.
Event or Problem Description
It was reported that the patient was experiencing inadequate stimulation.The patient underwent an explant procedure.Additional information was received that the explanted products were not returned.

• Brand Name: LINEAR
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 11454993
• Report Number: 3006630150-2021-00873
• Device Sequence Number: 17087998
• Product Code: LGW
• UDI-Device Identifier: 08714729767695
• UDI-Public: 08714729767695
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/18/2015
• Device Model Number: SC-2158-50
• Device Catalogue Number: SC-2158-50
• Device Lot Number: 16613516
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR