FDA Adverse Event Injury Summary report: N

QUATTRODE

MDR report key: 2821197 · Received October 25, 2012

Report

Report Number: 1627487-2012-13020
Event Type: Injury
Date Received: October 25, 2012
Date of Event: October 4, 2012
Report Date: October 4, 2012
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION
Product Code: LGW
PMA / PMN Number: P010032
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

RESULTS: THE COMPLAINT WAS CONFIRMED. THE LEAD THAT WAS RECEIVED WAS KINKED WITH 3 OF 4 WIRES BROKEN, APPROXIMATELY 14.5 CM FROM THE STIMULATION END. 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 2 OF 2. REFERENCE MFR REPORT: 1627487-2012-13019. IT WAS REPORTED THE PT WAS RESTLESS AND HAD SPORADIC BREATHING DUE TO EXTREME LEFT-SIDED PAIN; STIMULATION WAS NO LONGER REACHING THE PAIN PATTERN. REPROGRAMMING WAS ATTEMPTED, BUT NO STIMULATION WAS FELT. FOLLOW UP REPORTED THE PT WAS TAKEN INTO THE OPERATING ROOM AND THE IMPEDANCES WERE CHECKED FROM THE LEAD. THE DISTAL END OF THE LEAD WOULD NOT STAY CONNECTED IN THE CABLE AND THE READINGS WERE INVALID. TWO OTHER CABLES WERE ATTEMPTED WITH THE SAME RESULTS. THE PHYSICIAN DECIDED TO PULL THE FIRST LEAD AND IMPLANTED A NEW ONE SUCCESSFULLY. IT WAS REPORTED THE PT RECEIVED COMFORTABLE COVERAGE. IT IS UNDETERMINED WHICH LEAD WAS REMOVED, SO BOTH LOT NUMBERS ARE BEING REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	QUATTRODE	SCS LEAD	LGW	ST. JUDE MEDICAL - NEUROMODULATION	3153	3200233

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR		Required Intervention	IMPLANTED:\| SCS LEAD: MODEL 1194 (2)\| SCS EXTENSION: MODEL 3343\| SCS EXTENSION: MODEL 3386\| IMPLANTED:\| IMPLANTED: