FDA Adverse Event Injury Summary report: N

PRECISION NOVI

MDR report key: 8600250 · Received May 10, 2019

Report

Report Number: 3006630150-2019-02188
Event Type: Injury
Date Received: May 10, 2019
Date of Event: April 22, 2019
Report Date: May 10, 2019
Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION
Product Code: LGW
UDI-DI: 08714729897835
PMA / PMN Number: P030017
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5109745 / 5110735, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED 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 DEVELOPED AN INFECTION. IT WAS STATED THAT THE PATIENT WAS VERY SKINNY AND THE EDGE OF THE BATTERY WAS ERODING THROUGH THE SKIN. SIGN OF OOZING WAS NOTED. INFECTION WAS NOT DEVICE RELATED AND THE PHYSICIAN BELIEVED THAT NO PROPER CARE OF IMPLANT WAS THE CAUSE. ANTIBIOTICS WERE PRESCRIBED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
392635	PRECISION NOVI	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	BOSTON SCIENTIFIC NEUROMODULATION	SC-1140	20587146	08714729897835

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR		Required Intervention