MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION INFINION 16; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-2316-50E

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

Patient Problems Stroke/CVA (1770); Swelling/ Edema (4577)

Event Date 01/28/2021

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: scs-linear leads; upn: m365sc231650e0; model: sc-2316-50e; serial: (b)(4); batch: (b)(4).

Event Description

It was reported that the patient was hospitalized after having suffered a stroke, developing swelling in the legs, and a bakers cyst behind his knee the day after the trial leads were pulled.The patient is now doing better.No other information was provided.

• Brand Name: INFINION 16
• 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: 11402019
• MDR Text Key: 234391137
• Report Number: 3006630150-2021-00710
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729797807
• UDI-Public: 08714729797807
• 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,consum
• Type of Report: Initial
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/07/2022
• Device Model Number: SC-2316-50E
• Device Catalogue Number: SC-2316-50E
• Device Lot Number: 7113693
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2020
• 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): Hospitalization; Other
• Patient Age: 65 YR