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

Model Number	SC-1200
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Charging Problem (2892)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	11/21/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
A report was received that the patient was experiencing pain and tenderness at the ipg site.It was noted that the patient also had difficulty charging the ipg due to migration.The patient will undergo a revision procedure.
Additional Manufacturer Narrative
Additional information was received that the patient underwent a pocket revision and ipg replacement procedure.The physician was unsure if there was device malfunction.The patient was doing well postoperatively.The explanted 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 or Problem Description
A report was received that the patient was experiencing pain and tenderness at the ipg site.It was noted that the patient also had difficulty charging the ipg due to migration.The patient will undergo a revision procedure.

• Brand Name: PRECISION MONTAGE MRI
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 7116926
• Report Number: 3006630150-2017-05102
• Device Sequence Number: 1272782
• Product Code: LGW
• UDI-Device Identifier: 08714729907114
• UDI-Public: 08714729907114
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: 030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/14/2019
• Device Model Number: SC-1200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2017
• Supplement Date Received by Manufacturer: 12/29/2017
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 01/10/2018
• 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: Required Intervention
• Patient Age: 58 YR