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

Model Number	SC-2158-70
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: sc-2158-50; serial number: (b)(4); batch/lot number: 2000021900/20749337.Model/catalog description: linear lead kit 50 cm.
Event or Problem Description
A report was received that the patient was having inadequate stimulation due to lead migration.The patient underwent a lead replacement procedure.
Event or Problem Description
A report was received that the patient was having inadequate stimulation due to lead migration.The patient underwent a lead replacement procedure.
Additional Manufacturer Narrative
Sc-2158-70, sn: (b)(6).Device evaluation indicated that the devices passed all tests performed.Sc-2158-50 ,sn: (b)(6).Device evaluation indicated that the devices passed all tests performed.

• 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: 9684087
• Report Number: 3006630150-2020-00442
• Device Sequence Number: 3171540
• Product Code: LGW
• UDI-Device Identifier: 08714729767718
• UDI-Public: 08714729767718
• 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: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2020

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: 02/01/2019
• Device Model Number: SC-2158-70
• Device Catalogue Number: SC-2158-70
• Device Lot Number: 2000021941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 04/06/2020
• 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: 66 YR