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

Model Number	SC-2218-70E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Weakness (2145); No Code Available (3191)
Date of Event	05/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: model number/catalog number: sc-2218-70e, serial number: (b)(4), batch/lot number: 5061224, model/catalog description: linear st trial lead kit 70 cm.
Event or Problem Description
A report was received that during a trial procedure, the patient went to the emergency room due to severe pain in the upper back, arms and shoulder.The patient was unable to move the legs and subdural hematoma was noted.The physician opted to remove the trial leads as the patient was still having pain after an hour of no stimulation.The patient underwent a surgical procedure to resolve the hematoma and the physician confirmed that some of the patients movements had returned.

• Brand Name: LINEAR ST
• 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: 8648235
• Report Number: 3006630150-2019-02511
• Device Sequence Number: 1643875
• Product Code: LGW
• UDI-Device Identifier: 08714729820741
• UDI-Public: 08714729820741
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/28/2019

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: 05/23/2020
• Device Model Number: SC-2218-70E
• Device Catalogue Number: SC-2218-70E
• Device Lot Number: 5061034
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 05/28/2019
• 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: 74 YR