MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION MONTAGE MRI; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-1200

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

Patient Problems Seizures (2063); Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned to bsn.A review of the manufacturing documentation for the ipg revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.

Event Description

A report was received that the patient recently developed some medical issues, and was experiencing seizures, and bladder control problems.The patient was being kept sedated at the hospital with the stimulation turned off.The physician performed brain scan imaging and was not able to determine the cause of the seizures, however, the physician confirmed after reviewing images there was no concerns with lead movement or positioning of the device, and believes the event was not device related.

• Brand Name: PRECISION MONTAGE MRI
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 9427717
• MDR Text Key: 169561876
• Report Number: 3006630150-2019-07133
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729905943
• UDI-Public: 08714729905943
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030017
• 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
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/18/2019
• Device Model Number: SC-1200
• Device Catalogue Number: SC-1200
• Device Lot Number: 21148035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2017
• 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: 86 YR