FDA Adverse Event Injury Summary report: N

QUATTRODE

MDR report key: 2890795 · Received December 21, 2012

Report

Report Number: 1627487-2012-11891
Event Type: Injury
Date Received: December 21, 2012
Date of Event: December 2, 2012
Report Date: December 2, 2012
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION
Product Code: LGW
PMA / PMN Number: K072462
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

Description of Event or Problem · 1

DEVICE 4 OF 4. REFERENCE MFR REPORT: 1627487-2012-11888, 11889, 11890. IT WAS REPORTED THE PT WAS RECEIVING INCONSISTENT STIMULATION, AND SOMETIMES FELT SHOCKING SENSATIONS. THE SJM REP MET WITH THE PT AND DETERMINED THERE WERE MULTIPLE CONTACTS WITH LOW IMPEDANCES. F/U IDENTIFIED THE PHYSICIAN DETERMINED ONE OF THE EXTENSIONS HAD PARTIALLY PULLED OUT OF THE HEADER OF THE IPG (REFERENCE MFR REPORT: 1627487-2012-11859 FOR THE IPG). IT WAS REPORTED THE EXTENSIONS WERE REPLACED AND THE LEADS HAD NORMAL IMPEDANCES. IT WAS REPORTED ONE OF THE LEADS WAS REPOSITIONED FOR IMPROVED STIMULATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	QUATTRODE	SCS LEAD	LGW	ST. JUDE MEDICAL - NEUROMODULATION	3166	3224616

Patients

Seq	Age	Sex	Outcome	Treatment
1	33 YR		Required Intervention	SCS LEAD: MODEL 3149 (2)\| IMPLANT DATE: