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

Model Number SC-1200

Device Problems Unexpected Therapeutic Results (1631); Charging Problem (2892)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/05/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced inadequate stimulation.It was also noted that the patient had difficulty charging the ipg.The patient underwent an ipg replacement procedure and was doing well postoperatively.The explanted ipg will not be returned.

Event Description

It was reported that the patient experienced inadequate stimulation.It was also noted that the patient had difficulty charging the ipg.The patient underwent an ipg replacement procedure and was doing well postoperatively.The explanted ipg will not be returned.

Manufacturer Narrative

Sc-1200.Sn: (b)(6).The returned ipg was analyzed, passed all tests performed, and exhibited normal device characteristics.

• 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: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 15609006
• MDR Text Key: 301772413
• Report Number: 3006630150-2022-05544
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

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: 10/17/2019
• Device Model Number: SC-1200
• Device Catalogue Number: SC-1200
• Device Lot Number: 21264936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/14/2022
• Supplement Dates Manufacturer Received: 08/25/2023
• Supplement Dates FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2017
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 70 KG