FDA Adverse Event Injury Summary report: N

INSPIRE UPPER AIRWAY STIMULATION SYSTEM

MDR report key: 4922030 · Received July 9, 2015

Report

Report Number: 3007666314-2015-00003
Event Type: Injury
Date Received: July 9, 2015
Date of Event: June 12, 2015
Report Date: July 9, 2015
Manufacturer: INSPIRE MEDICAL SYSTEMS INC
Product Code: MNQ
PMA / PMN Number: P130008
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

MODEL 3024 NEUROSTIMULATOR SERIAL # (B)(4) MANUFACTURER DATE 06/28/2014, EXPIRATION DATE 06/28/2016, (B)(4). MODEL 4063 STIMULATION LEAD SERIAL # (B)(4) - MANUFACTURER DATE 09/01/2014, EXPIRATION DATE- 09/01/2016, (B)(4). MODEL 4323 SENSING LEAD SERIAL # (B)(4) - MANUFACTURE DATE 07/13/2014, EXPIRATION DATE 07/13/2016, (B)(4).: EXACT IMPLANT DATE UNKNOWN BUT APPROXIMATE IMPLANT DATE IS (B)(6) 2015. THREE REQUESTS FOR RETURN OF THE DEVICES FROM THE USER FACILITY HAVE BEEN MADE BUT USER FACILITY IS UNWILLING TO RETURN THEM.

Description of Event or Problem · 1

TWO MONTHS AFTER IMPLANT THE PATIENT DEVELOPED A SMALL AREA OF GRANULATION/SUPERFICIAL INFECTION IN THE SENSOR WOUND. THE PHYSICIAN INITIALLY TREATED THE PATIENT WITH TOPICAL AND ORAL ANTIBIOTICS AND THEN ON (B)(6) 2015 EXPLANTED THE ENTIRE SYSTEM. THE EXPLANT PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ISSUE. NO SIGN OF INFECTION WAS NOTED AT THE STIMULATION LEAD IMPLANT SITE HOWEVER SIGNS OF INFECTION WERE NOTED AT THE IPG AND SENSOR LEAD IMPLANT SITES. ALL INCISION SITES WERE THOROUGHLY IRRIGATED WITH ANTIBIOTIC LACED SALINE SOLUTION. THE ORIGIN OF THE INFECTION IS UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
446570	INSPIRE UPPER AIRWAY STIMULATION SYSTEM	LEADS AND NEUROSTIMULATOR	MNQ	INSPIRE MEDICAL SYSTEMS INC	3024, 4323, 4063

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention