FDA Adverse Event Injury Summary report: N

PRECISION MONTAGE MRI

MDR report key: 8580207 · Received May 3, 2019

Report

Report Number: 3006630150-2019-02051
Event Type: Injury
Date Received: May 3, 2019
Date of Event: April 10, 2019
Report Date: May 3, 2019
Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION
Product Code: LGW
UDI-DI: 08714729905943
PMA / PMN Number: P030017
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

MODEL NUMBER/CATALOG NUMBER: SC-2408-56, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 21387927/5022355, MODEL/CATALOG DESCRIPTION: AVISTA MRI PERC LEAD KIT 56 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATE TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE DEVICES WERE FOUND TO BE SATISFACTORY.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT DEVELOPED AN INFECTION AT THE INCISION SITE. IT WAS NOTED THAT THE INCISION WAS SLIGHTLY OPENED AND RED. THE INFECTION WAS NOT DEVICE RELATED. THE PHYSICIAN OBSERVED THE ABSENCE OF DERMABOND LIQUID DRESSING FOLLOWING A PROCEDURE. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
372694	PRECISION MONTAGE MRI	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	BOSTON SCIENTIFIC NEUROMODULATION	SC-1200	359729	08714729905943

Patients

Seq	Age	Sex	Outcome	Treatment
1	45 YR		Required Intervention