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

Model Number SC-2317-70

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); No Code Available (3191)

Event Date 09/27/2020

Event Type  Injury  

Event Description

It was reported that the patient experienced radiculopathy in the lumbar region which was mild in severity.Patient was given medication and device was reprogrammed.The physician assessed that this issue was not related to the procedure and has a probable relationship to hardware and stimulation.The patient is recovering and the issue is resolving.

• 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; RQ 00646-2602
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 10712368
• MDR Text Key: 212318184
• Report Number: 3006630150-2020-05054
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729861638
• UDI-Public: 08714729861638
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/23/2021
• Device Model Number: SC-2317-70
• Device Catalogue Number: SC-2317-70
• Device Lot Number: 5137944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2019
• 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: 63 YR