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

Model Number	SC-1112
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Fever (1858); Sepsis (2067); Swelling (2091)
Date of Event	12/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted devices were not returned to bsn as they were discarded by the medical facility.The model number and serial numbers of the explanted lead or leads is currently unknown.
Event or Problem Description
A report was received that the patient was experiencing dizziness, fever and a swollen face.The physician assessed that the patient had a non-device related infection and sepsis in the blood.The patient was hospitalized and was assessed to be in serious condition.The patient was administered antibiotics and an explant of the entire system was conducted.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model: sc-2352-70 serial/lot: (b)(4) description: linear 3-4 lead, 70cm model: sc-4318 serial/lot: (b)(4) descripcription: clik x anchor it is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint devices 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 was experiencing dizziness, fever and a swollen face.The physician assessed that the patient had a non-device related infection and sepsis in the blood.The patient was hospitalized and was assessed to be in serious condition.The patient was administered antibiotics and an explant of the entire system was conducted.

• Brand Name: PRECISION MULTIWAVE
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 7216966
• Report Number: 3006630150-2018-00333
• Device Sequence Number: 16179023
• Product Code: LGW
• UDI-Device Identifier: 08714729837138
• UDI-Public: 08714729837138
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: 030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2018

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: 08/24/2018
• Device Model Number: SC-1112
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2017
• Supplement Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 01/24/2018
• Supplement Report FDA Received Date: 02/23/2018
• 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; Other; Required Intervention