FDA Adverse Event Injury Summary report: N

LINEAR ST

MDR report key: 8693938 · Received June 12, 2019

Report

Report Number: 3006630150-2019-02763
Event Type: Injury
Date Received: June 12, 2019
Date of Event: May 22, 2019
Report Date: June 12, 2019
Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION
Product Code: LGW
UDI-DI: 08714729767725
PMA / PMN Number: P030017
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5113731, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. MODEL NUMBER/CATALOG NUMBER: SC-2218-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5087681 / 5089866, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM. MODEL NUMBER/CATALOG NUMBER: SC-1160, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 348933, MODEL/CATALOG DESCRIPTION: SPECTRA WAVEWRITER IPG KIT. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE DEVICES WAS FOUND TO BE SATISFACTORY.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE INCISION SITES. SYMPTOMS WERE DRAINAGE AND AN OPEN WOUND. THE PHYSICIAN BELIEVED THAT NOTHING HAPPENED DURING THE PROCEDURE THAT MAY HAVE CAUSED THIS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS GIVEN ANTIBIOTICS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
487718	LINEAR ST	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	BOSTON SCIENTIFIC NEUROMODULATION	SC-2218-50	5113730	08714729767725

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR		Required Intervention