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

Model Number SC-2352-50E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seizures (2063)

Event Date 04/14/2018

Event Type  Injury  

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 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.

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 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
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 7500650
• MDR Text Key: 107795857
• Report Number: 3006630150-2018-01576
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729789703
• UDI-Public: 08714729789703
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/30/2019
• Device Model Number: SC-2352-50E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR