MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION COVEREDGE 32; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-8336-50

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

Patient Problems Hematoma (1884); High Blood Pressure/ Hypertension (1908); Paralysis (1997)

Event Date 01/20/2022

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: unk, upn: unk, model: unk, serial: unk, batch: unk.

Event Description

It was reported that before being discharged, following a spinal cord stimulator trial procedure where the distal end of the lead was placed at the seventh thoracic vertebra, the patient experienced high blood pressure and was unable to move his extremities.The patient was admitted to the hospital and the physician assessed that the cause of the symptoms was a small hematoma that was not related to the device.The patients function returned to normal and he was released from the hospital.

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: scs-extension, upn: m365sc3138250, model: sc-3138-25, serial: (b)(6), batch: 7030150.Product family: scs-extension, upn: m365sc3138250, model: sc-3138-25, serial: (b)(6), batch: 5083896.Product family: scs-extension, upn: m365sc3138250, model: sc-3138-25, serial: (b)(6), batch: 5082069.Product family: scs-extension, upn: m365sc3138250, model: sc-3138-25, serial: (b)(6), batch: 7070769.

Event Description

It was reported that before being discharged, following a spinal cord stimulator trial procedure where the distal end of the lead was placed at the seventh thoracic vertebra, the patient experienced high blood pressure and was unable to move his extremities.The patient was admitted to the hospital and the physician assessed that the cause of the symptoms was a small hematoma that was not related to the device.The patients function returned to normal and he was released from the hospital.

• Brand Name: COVEREDGE 32
• 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: 13540098
• MDR Text Key: 285664481
• Report Number: 3006630150-2022-00526
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729832669
• UDI-Public: 08714729832669
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/21/2023
• Device Model Number: SC-8336-50
• Device Catalogue Number: SC-8336-50
• Device Lot Number: 7075116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male