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 Problems Undesired Nerve Stimulation (1980); Pain (1994); Inadequate Pain Relief (2388)

Event Date 05/14/2021

Event Type  Injury  

Event Description

It was reported that the patient was not receiving adequate stimulation coverage since the lead revision procedure (mfr.Report number: 3006630150-2021-02806).It was noted that the patient was experiencing pain in the left leg even when stimulation was turned on or off.The patient also mentioned that the stimulation was affecting his pulse rate.Reprogramming was performed, however, unsuccessful.The patient underwent an ipg explant procedure.

Event Description

It was reported that the patient was not receiving adequate stimulation coverage since the lead revision procedure (mfr.Report number: 3006630150-2021-02806).It was noted that the patient was experiencing pain in the left leg even when stimulation was turned on or off.The patient also mentioned that the stimulation was affecting his pulse rate.Reprogramming was performed, however, unsuccessful.The patient underwent an ipg explant procedure.Additional information was received that the explanted device was discarded by the medical facility.No further information has been obtained despite good faith efforts.

• 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
• MDR Report Key: 12394295
• MDR Text Key: 269021070
• Report Number: 3006630150-2021-04892
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729905943
• UDI-Public: 08714729905943
• Combination Product (y/n): N
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2022
• Device Model Number: SC-1200
• Device Catalogue Number: SC-1200
• Device Lot Number: 372327
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR