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

Model Number SC-1232

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

Patient Problems Paralysis (1997); Thrombosis/Thrombus (4440)

Event Date 03/22/2020

Event Type  Injury  

Manufacturer Narrative

Follow up: other- family member.

Event Description

It was reported by the patients spouse that following a laminectomy and spinal cord stimulator implant procedure, the patient developed a blood clot.The patient was admitted to the hospital the following day and later underwent a procedure to remove the clot.The patient experienced neurological deficits, no sensation in the midsection, and was unable to stand, therefore, the patient was discharge to a rehabilitation facility on (b)(6) 2021.The prognosis is unknown and no further information is able to be obtained regarding the device serial number or patient status.

• Brand Name: WAVEWRITER ALPHA
• 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 Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 11877964
• MDR Text Key: 252724111
• Report Number: 3006630150-2021-02355
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SC-1232
• Device Catalogue Number: SC-1232
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention