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

Model Number	SC-2158-70
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: 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: m365sc2158700, model: sc-2158-70, serial: (b)(4), batch: 242101.
Event or Problem Description
It was reported that after a non-device related surgery, the patients leads have been cut or damaged.
Event or Problem Description
It was reported that after a non-device related surgery, the patients leads have been cut or damaged.Additional information was received that an electrocautery was used during the non-device related surgery.The patient underwent a lead replacement procedure and was doing well postoperatively.The explanted leads were discarded.Per the physicians implant manual, electrocautery is a known source of high voltage transient signal and warns against the use of electrocautery.

• 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: 12201903
• Report Number: 3006630150-2021-03936
• Device Sequence Number: 3441477
• Product Code: LGW
• UDI-Device Identifier: 08714729767718
• UDI-Public: 08714729767718
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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: 05/31/2010
• Device Model Number: SC-2158-70
• Device Catalogue Number: SC-2158-70
• Device Lot Number: 240256
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/09/2021
• 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: 67 YR