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

Model Number	SC-3400-30
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: exact date unknown, event occurred couple months ago from the date manufacturer became aware of the event.
Event or Problem Description
It was reported that the patient was having loss of stimulation due to high impedances.The patient underwent a spinal cord stimulator revision procedure wherein a splitter was replaced and resolved four out of five contacts with high impedance.The patient was doing well postoperatively.
Additional Manufacturer Narrative
Sc-3400-30 sn: (b)(6).The returned splitter was analyzed and showed that cables were fractured near one of the proximal ends.With all the available information, boston scientific concludes the reported event was confirmed.The lead got kinked after the rigid proximal ends resulting in the cable fractures when excessive force was exerted onto the lead which caused the reported patient experience.Thus the probable cause was traced to component failure.
Event or Problem Description
It was reported that the patient was having loss of stimulation due to high impedances.The patient underwent a spinal cord stimulator revision procedure wherein a splitter was replaced and resolved four out of five contacts with high impedance.The patient was doing well postoperatively.

• 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: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12878143
• Report Number: 3006630150-2021-06741
• Device Sequence Number: 4434238
• Product Code: LGW
• UDI-Device Identifier: 08714729797838
• UDI-Public: 08714729797838
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• 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): 12/30/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/23/2017
• Device Model Number: SC-3400-30
• Device Catalogue Number: SC-3400-30
• Device Lot Number: 17901802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 11/26/2021
• Supplement Report FDA Received Date: 12/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2015
• 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: 50 YR
• Patient Sex: Female