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

Model Number SC-2218-50

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

Patient Problems Nerve Damage (1979); Numbness (2415)

Event Date 10/17/2017

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: model#: sc-2218-50, serial#: (b)(4), description: linear st lead, 50.Model#: sc-1200, serial#: (b)(4), description: precision montage mri ipg sterile kit the explanted devices were not returned to bsn as they were kept by the facility.

Event Description

A report was received that following the patients implant procedure the patient was experiencing foot numbness.The physician ordered a magnetic resonance imaging (mri) for the patient and the result came back negative.The physician suspected the lead on the 11-12 thoracic level due to having a lot of stenosis and it maybe pinching down on a nerve.The patient underwent an explant procedure.No device malfunction was suspected.The patient was doing well postoperatively.

• Brand Name: PRECISION MONTAGE MRI
• 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: 7006632
• MDR Text Key: 91240358
• Report Number: 3006630150-2017-04410
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767725
• UDI-Public: 08714729767725
• 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
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/22/2017
• Device Model Number: SC-2218-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2017
• 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): Required Intervention
• Patient Age: 84 YR