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

Model Number SC-2317-70

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Inadequate Pain Relief (2388)

Event Date 03/16/2022

Event Type  Injury  

Event Description

It was reported that the patient was receiving inadequate therapy.It was noted the during the original implant procedure, the physician found the patient had a very difficult spine to gain access and place the leads.As such, he was only able to implant one of the leads.The patient underwent a revision procedure and the physician replaced the infinion lead and implanting a coveredge paddle lead.No additional adverse patient effects were reported.The patient is expected to recover normally.The explanted lead will not be returned as it was discarded at the facility.

Manufacturer Narrative

Correction to initial mdr in box b5.

Event Description

It was reported that the patient was receiving inadequate therapy.It was noted the during the original implant procedure, the physician found the patient had a very difficult spine to gain access and place the leads.As such, he was only able to implant one of the leads.The patient underwent a revision procedure and the physician explanted the infinion lead and implanting a coveredge paddle lead.There was no device malfunction suspected.No additional adverse patient effects were reported.The patient is expected to recover normally.The explanted lead will not be returned as it was discarded at the facility.

• Brand Name: INFINION CX
• 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: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 13841437
• MDR Text Key: 287558648
• Report Number: 3006630150-2022-01138
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729861638
• UDI-Public: 08714729861638
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/19/2023
• Device Model Number: SC-2317-70
• Device Catalogue Number: SC-2317-70
• Device Lot Number: 7074375
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2021
• 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 Sex: Female