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	Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patients lead had high impedances.The patients leads were explanted wherein the left cervical leads distal tip were left behind.The patient was doing well postoperatively.
Additional Manufacturer Narrative
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: m365sc2218500; model: sc-2218-50; serial: (b)(4); batch: 20668686.
Additional Manufacturer Narrative
Sc-2158-70 sn: (b)(6).The returned lead was analyzed, and x-ray inspection revealed that one of the cables was fractured within the distal array.With all the available information, boston scientific concludes the reported event was confirmed.The distal tip and electrode were separated from the distal array.The cables are exposed at the damaged portion of the lead.It appears that resistances were felt during the lead pull and was subjected to an excessive tensile load causing damage to the distal array.The probable cause was unintended use error which caused or contributed to the event.Sc-2218-50 sn: (b)(6).The returned lead was analyzed, passed all tests performed, and exhibited normal device characteristics.
Event or Problem Description
It was reported that the patients lead had high impedances.The patients leads were explanted wherein the left cervical leads distal tip were left behind.The patient was doing well postoperatively.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 15663950
• Report Number: 3006630150-2022-05737
• Device Sequence Number: 6385591
• Product Code: LGW
• UDI-Device Identifier: 08714729767718
• UDI-Public: 08714729767718
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/17/2019
• Device Model Number: SC-2158-70
• Device Catalogue Number: SC-2158-70
• Device Lot Number: 20511936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female