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

Model Number	SC-4319
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Irritation (1941)
Date of Event	06/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted device was not returned to bsn.
Event or Problem Description
A report was received that the patient was experiencing irritation at the clik anchor site.The patient underwent a revision procedure wherein the clik anchor was replaced and placed deeper.No device malfunction was suspected.The patient was doing well postoperatively.

• 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: 6720084
• Report Number: 3006630150-2017-02586
• Device Sequence Number: 1735986
• Product Code: LGW
• UDI-Device Identifier: 08714729905325
• UDI-Public: (01)08714729905325(17)180125(10)18967969
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Report Date (Section B): 06/25/2017

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: 01/25/2018
• Device Model Number: SC-4319
• Device Lot Number: 18967969
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2017
• Initial Report FDA Received Date: 07/17/2017
• 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: 61 YR