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

Model Number	SC-4252
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); No Code Available (3191)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a trial procedure the tunneling tool was not sharp enough on the top.The patient was experiencing discomfort and pain due to the surgeons extra effort during the tunneling, and an extra suture was required.The physician feels that the patient had an increased risk of infection due to adding the extra suture.The patient was admitted to hospital beyond standard of care.The procedure was successful and the patient has fully recovered.
Event or Problem Description
It was reported that during a trial procedure the tunneling tool was not sharp enough on the top.The patient was experiencing discomfort and pain due to the surgeons extra effort during the tunneling, and an extra suture was required.The physician feels that the patient had an increased risk of infection due to adding the extra suture.The patient was admitted to hospital beyond standard of care.The procedure was successful and the patient has fully recovered.
Additional Manufacturer Narrative
Box h6 3191 no code available was used as there is no equivalent fda code for surgical intervention.The returned tunneling tool was analyzed and no anomalies were found.Visual inspection revealed the tip was intact and sharpened.The tunneling tool tip was used to successfully penetrate/cut various materials.The devices exhibit normal device characteristics.

• 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
• MDR Report Key: 10891418
• Report Number: 3006630150-2020-05772
• Device Sequence Number: 19661990
• Product Code: LGW
• UDI-Device Identifier: 08714729784456
• UDI-Public: 08714729784456
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2020

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: Health Professional
• Device Expiration Date: 08/20/2022
• Device Model Number: SC-4252
• Device Catalogue Number: SC-4252
• Device Lot Number: 25785785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 12/28/2020
• 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: Hospitalization; Required Intervention