MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA; SPINAL CORD STIMULATOR

Model Number	SC-2218-70E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Fever (1858)
Date of Event	05/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.
Event or Problem Description
A report was received that the patient developed superficial infection at the lead site after the trial leads were pulled out.The patient had fever and the infection was related to superficial needle entry.The patient was admitted to the hospital due to possible epidural abscess and was administered intravenous antibiotics.The patient was doing well.

• Brand Name: PRECISION SPECTRA
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 6602868
• Report Number: 3006630150-2017-02017
• Device Sequence Number: 1267139
• Product Code: LGW
• UDI-Device Identifier: 08714729820741
• UDI-Public: (01)08714729820741(17)181110(10)19937712
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: 030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2017

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: 11/10/2018
• Device Model Number: SC-2218-70E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2017
• Initial Report FDA Received Date: 05/31/2017
• 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
• Patient Age: 40 YR