FDA Adverse Event Injury Summary report: N

WAVEWRITER ALPHA

MDR report key: 17243423 · Received June 30, 2023

Report

Report Number: 3006630150-2023-03821
Event Type: Injury
Date Received: June 30, 2023
Date of Event: June 2, 2023
Report Date: June 30, 2023
Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION
Product Code: LGW
UDI-DI: 08714729985099
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED DAYS PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS-MRI, UPN: M365SC8436500, MODEL: SC-8436-50, SERIAL: (B)(6), BATCH: 7080542.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE PATIENTS POCKET INCISION HAD OPENED. THE PHYSICIAN NOTED BLEEDING, HEMATOMA AND SEROMA ON THE POCKET SITE. THE PATIENT WENT TO THE EMERGENCY ROOM AND THE POCKET WAS CLOSED, AND THE PATIENT WAS SENT HOME. THE POCKET INCISION OPENED AGAIN AFTER A FEW DAYS, AND THE PATIENT WAS PLACED ON ANTIBIOTICS AND STERI STRIPS WERE APPLIED OVER THE INCISION SITE. THE PHYSICIAN OPTED TO REMOVE THE SPINAL CORD STIMULATOR (SCS) SYSTEM AS THE POCKET SITE KEPT OPENING BACK UP. THE PATIENT WAS HEALING WELL POSTOPERATIVELY. ALL DEVICE COMPONENTS WERE DISCARDED BY THE MEDICAL FACILITY. NO DEVICE MALFUNCTION SUSPECTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1344038	WAVEWRITER ALPHA	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	BOSTON SCIENTIFIC NEUROMODULATION	SC-1232	566793	08714729985099

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR	Female	Required Intervention