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

Model Number	SC-4108
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Skin Irritation (2076); No Code Available (3191)
Date of Event	01/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
A report was received that the patient had a small skin blister at the trial or cable site upon removing the spinal cord stimulator trial.The physician believed that the blister was a result from the friction applied from the or box bandaged to the patients skin on a normal day to day actions during the trial.
Event or Problem Description
A report was received that the patient had a small skin blister at the trial or cable site upon removing the spinal cord stimulator trial.The physician believed that the blister was a result from the friction applied from the or box bandaged to the patients skin on a normal day to day actions during the trial.
Additional Manufacturer Narrative
Additional information was received that the patient was provided with antibacterial cream to treat the skin blisters and was bandaged up.The patient was reportedly doing well.The used device was not returned to bsn as it was discarded by the medical facility.

• Brand Name: PRECISION
• 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: 9681251
• Report Number: 3006630150-2020-00429
• Device Sequence Number: 3445315
• Product Code: LGW
• UDI-Device Identifier: 08714729821533
• UDI-Public: 08714729821533
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/18/2021
• Device Model Number: SC-4108
• Device Catalogue Number: SC-4108
• Device Lot Number: 23451879
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 03/04/2020
• 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: Required Intervention
• Patient Age: 78 YR