FDA Adverse Event Injury Summary report: N

QUATTRODE LEAD WIDE SPACED, 90 CM

MDR report key: 6655578 · Received June 20, 2017

Report

Report Number: 1627487-2017-03312
Event Type: Injury
Date Received: June 20, 2017
Date of Event: May 24, 2017
Report Date: July 21, 2017
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION
Product Code: GZF
PMA / PMN Number: K072462
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

IN THE EVENT THE DEVICE IS RETURNED TO THE MANUFACTURER, THE REPORTED EVENT CANNOT BE ANALYZED VIA LABORATORY TESTING. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

Description of Event or Problem · 1

DEVICE 2 OF 4. REFERENCE MFR. REPORT#: 1627487-003315; REFERENCE MFR. REPORT#: 1627487-003313; REFERENCE MFR. REPORT#: 1627487-003314. FOLLOW-UP INFORMATION REVEALED THE PATIENT'S INFECTION WAS RESOLVING. NO OTHER INTERVENTIONS HAVE BEEN PLANNED.

Description of Event or Problem · 1

DEVICE 2 OF 4. REFERENCE MFR. REPORT#: 1627487-003315, REFERENCE MFR. REPORT#: 1627487-003313, REFERENCE MFR. REPORT#: 1627487-003314. IT WAS REPORTED THE PATIENT HAS AN INFECTION AT THE RIGHT SUPRA-ORBITAL (OFF-LABEL) LEAD SITE. IT IS UNKNOWN WHEN THE INFECTION FIRST STARTED. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND THE INFECTION WILL BE MONITORED. FOLLOW-UP INFORMATION REVEALED THE PATIENT HAS COMPLETED THE ANTIBIOTICS AND WILL MEET WITH A SURGEON AS THE NEXT COURSE OF ACTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
434401	QUATTRODE LEAD WIDE SPACED, 90 CM	SCS LEAD	GZF	ST. JUDE MEDICAL - NEUROMODULATION	3169	4920461

Patients

Seq	Age	Sex	Outcome	Treatment
1	44 YR