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

Model Number SC-1432

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

Patient Problems Fall (1848); Hematoma (1884); Unspecified Infection (1930); Cognitive Changes (2551); Insufficient Information (4580)

Event Date 05/22/2022

Event Type  Injury  

Manufacturer Narrative

Exact date unknown, event occurred a day or two from date manufacturer was made aware.

Event Description

It was reported that the patient had a non-device related fall and had a large hematoma over the battery site.It was also reported that the patient was having possible infection in the spine and dementia.The patient was admitted to the hospital to rule out infection and was placed on antibiotics.

• Brand Name: WAVEWRITER ALPHA PRIME
• 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; cashel road; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 14911688
• MDR Text Key: 295235859
• Report Number: 3006630150-2022-03277
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729985075
• UDI-Public: 08714729985075
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 07/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/12/2024
• Device Model Number: SC-1432
• Device Catalogue Number: SC-1432
• Device Lot Number: 209266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2022
• 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: 78 YR
• Patient Sex: Male