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

Model Number SC-2408-74

Device Problem Unexpected Therapeutic Results (1631)

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

Event Date 03/02/2022

Event Type  Injury  

Event Description

It was reported that the patient was experiencing loss of stimulation and stimulation on non target area despite of multiple reprogramming done.It was also reported that the patient was experiencing inadequate stimulation due to lead placement.The patient underwent an explant procedure.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: scs-ipg-r-mri, upn: (b)(4), model: sc-1232, serial: (b)(4), batch: 532221.Product family: scs-linear leads-mri, upn: (b)(4), model: sc-2408-74, serial: (b)(4), batch: 7073751.

Event Description

It was reported that the patient was experiencing loss of stimulation and undesired stimulation in non-target area despite of multiple reprogramming done.It was also reported that the patient was experiencing inadequate stimulation due to lead placement.The patient underwent an explant procedure.Additional information was received that the patients ipg and leads were explanted and will not be returned.

• Brand Name: AVISTA 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 15705255
• MDR Text Key: 302765397
• Report Number: 3006630150-2022-05881
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729904823
• UDI-Public: 08714729904823
• 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: Consumer,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/12/2023
• Device Model Number: SC-2408-74
• Device Catalogue Number: SC-2408-74
• Device Lot Number: 7073749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2021
• 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: 69 YR
• Patient Sex: Male