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

Model Number	SC-3138-35
Medical Device Problem Codes	Fracture (1260); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was experiencing inadequate stimulation despite reprogramming attempts.During the surgery, the physician took the extensions off the leads and found out that both extensions were snapped in half and physician suspected it was due to patients bending over too hard.The patient underwent a revision procedure wherein lead extentsions were replaced.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-extension upn: m365sc3138350 model: sc-3138-35 serial: (b)(6).Batch:19056736.
Event or Problem Description
It was reported that the patient was experiencing inadequate stimulation despite reprogramming attempts.During the surgery, the physician took the extensions off the leads and found out that both extensions were snapped in half and physician suspected it was due to patients bending over too hard.The patient underwent a revision procedure wherein lead extensions were replaced.
Additional Manufacturer Narrative
Correction to the initial mdr in blocks d4, h4 and h10.Additional suspect medical device component involved in the event: product family: scs-extension upn: m365sc3138350 , model: sc-3138-35, serial: (b)(6), batch: 16620823.Sc-3138-35 sn: (b)(6) the returned lead extensions were analyzed, and visual inspection revealed that the lead extension tails were completely separated from the lead extension connector.Electrical test could not be performed due the damaged lead extension.It appears that excessive mechanical force was exerted onto the lead extension resulting in multiple cable fractures and the lead extension tails separation from the lead extension connector.With all the available information, boston scientific concludes that the allegation of lead extension damage was confirmed.Damage to the lead extension caused the reported pain and inadequate stimulation.It was also reported that the physician suspected that it was due to patients bending over too hard.

• Brand Name: NA
• 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: 16900705
• Report Number: 3006630150-2023-02614
• Device Sequence Number: 6791608
• Product Code: LGW
• UDI-Device Identifier: 08714729760559
• UDI-Public: 08714729760559
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: 2023
• 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): 08/03/2023

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: 01/08/2016
• Device Model Number: SC-3138-35
• Device Catalogue Number: SC-3138-35
• Device Lot Number: 16620823
• 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: 04/19/2023
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2014
• 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: 52 YR
• Patient Sex: Female