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

Model Number	SC-2352-50E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seizures (2063)
Date of Event	04/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model #: sc-2352-50e, serial #: (b)(4), description: trial linear 3-4 lead, 50cm.
Event or Problem Description
A report was received that immediately following a trial procedure, the patient had epilepsy and was having a seizure.The patient was transported to a hospital and was placed in neuro intensive care unit (icu) as they were unable to get the seizures under control.The physician believed that the seizure was not related to the device or procedure.It was noted that the patient was a known epileptic and had history of seizures.The physician removed the leads while the patient was in the hospital.
Additional Manufacturer Narrative
Additional information was received that the cause of seizure was extremely low medication levels and was believed to be non-procedure related.The patient was doing well.
Event or Problem Description
A report was received that immediately following a trial procedure, the patient had epilepsy and was having a seizure.The patient was transported to a hospital and was placed in neuro intensive care unit (icu) as they were unable to get the seizures under control.The physician believed that the seizure was not related to the device or procedure.It was noted that the patient was a known epileptic and had history of seizures.The physician removed the leads while the patient was in the hospital.

• 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: 7500650
• Report Number: 3006630150-2018-01576
• Device Sequence Number: 19378855
• Product Code: LGW
• UDI-Device Identifier: 08714729789703
• UDI-Public: 08714729789703
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: 030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2018

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: 10/30/2019
• Device Model Number: SC-2352-50E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 05/29/2018
• 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; Required Intervention
• Patient Age: 51 YR