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

Model Number SC-1200

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/11/2022

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: scs-linear leads, upn: (b)(4), model: sc-2352-50, serial: (b)(4), batch: (b)(4).Product family: scs-linear leads upn: (b)(4), model: sc-2352-50, serial: (b)(4), batch: (b)(4).

Event Description

It was reported that the patient experienced inadequate stimulation despite numerous attempts to reprogram the device.The patient underwent an explant procedure.

• 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: 15188222
• MDR Text Key: 297488013
• Report Number: 3006630150-2022-03908
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729905943
• UDI-Public: 08714729905943
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/08/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/25/2020
• Device Model Number: SC-1200
• Device Catalogue Number: SC-1200
• Device Lot Number: 21629107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2018
• 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