FDA Adverse Event Injury Summary report: N

LINEAR ST

MDR report key: 9611034 · Received January 21, 2020

Report

Report Number: 3006630150-2020-00122
Event Type: Injury
Date Received: January 21, 2020
Date of Event: December 30, 2019
Report Date: January 21, 2020
Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION
Product Code: LGW
UDI-DI: 08714729767725
PMA / PMN Number: P030017
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5103246, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING UNDESIRED STIMULATION ON NON TARGETED AREA DUE TO LEAD MIGRATION. THE PATIENT WAS ABOUT TO HAVE A LEAD READJUSTMENT, HOWEVER, DURING THE PROCEDURE IT WAS FOUND OUT THAT THE PATIENT HAD AN INFECTION AT THE MIDLINE INCISION. SYMPTOM OF PUS WAS NOTED. IT WAS ALSO REPORTED THAT THE PHYSICIAN WAS UNSURE IF INFECTION WAS DEVICE RELATED AND THE CAUSE WAS UNKNOWN. THE PATIENT WAS PLACED ON ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
76382	LINEAR ST	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	BOSTON SCIENTIFIC NEUROMODULATION	SC-2218-50	5100432	08714729767725

Patients

Seq	Age	Sex	Outcome	Treatment
1	44 YR		Required Intervention