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

Model Number	SC-2352-50E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of birth: (b)(6).Additional suspect medical device component involved in the event: model # sc-2352-50e serial # (b)(4) description: linear 3-4 lead, 50cm it is indicated that the trial leads will not be returned for evaluation; therefore a failure analysis of the complaint devices could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.
Event or Problem Description
A report was received that the patient developed pain above and around the leads entry site after the trial procedure.The leads were explanted earlier than planned and the event has resolved.The physician assessed that the pain was device, procedure and stimulation related.
Event or Problem Description
A report was received that the patient developed pain above and around the leads entry site after the trial procedure.The leads were explanted earlier than planned and the event has resolved.The physician assessed that the pain was device, procedure and stimulation related.
Additional Manufacturer Narrative
Additional information was received that the event was related to the study procedure and not related to the study device.
Event or Problem Description
A report was received that the patient developed pain above and around the leads entry site after the trial procedure.The leads were explanted earlier than planned and the event has resolved.The physician assessed that the pain was device, procedure and stimulation related.

• Brand Name: LINEAR 3-4
• 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: 6574168
• Report Number: 3006630150-2017-01840
• Device Sequence Number: 10901519
• Product Code: LGW
• UDI-Device Identifier: 08714729789703
• UDI-Public: (01)08714729789703(17)180104(10)18744967
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2019

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: 01/04/2018
• Device Model Number: SC-2352-50E
• Device Catalogue Number: SC-2352-50E
• Device Lot Number: 18744967
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2017
• Supplement Date Received by Manufacturer: Not provided; 06/27/2019
• Initial Report FDA Received Date: 05/17/2017
• Supplement Report FDA Received Date: 06/20/2017; 07/16/2019
• 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