FDA Adverse Event Injury Summary report: N

QUATTRODE

MDR report key: 3950496 · Received July 10, 2014

Report

Report Number: 1627487-2014-05479
Event Type: Injury
Date Received: July 10, 2014
Date of Event: March 6, 2014
Report Date: June 14, 2014
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION
Product Code: GZB
PMA / PMN Number: P010032
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

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 1 OF 3. REFERENCE MFR. REPORT#: 1627487-2014-05480, REFERENCE MFR. REPORT#: 1627487-2014-05481. THE PATIENT HAS TWO LEADS FROM THE SAME LOT. IT WAS REPORTED THE PATIENT ((B)(6)) HAD HIGH/INVALID IMPEDANCE ON ONE OF THEIR LEADS. IN TURN, THE PATIENT LOST EFFECTIVE THERAPY. X-RAYS WERE TAKEN AND REVEALED NO ANOMALIES. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2014. DURING THE PROCEDURE, THE LEFT LEAD WAS FOUND TO BE FRACTURED AND COULD NOT BE TESTED. THE RIGHT LEAD WAS TESTED WITH A TRIAL CABLE AND NORMAL IMPEDANCE WAS PRESENT. THE RIGHT LEAD WAS TESTED WHEN CONNECTED TO THE RIGHT AND LEFT EXTENSION AND IMPEDANCE ISSUES REMAINED. AS A RESULT, THE DOCTOR EXPLANTED AND REPLACED THE LEFT AND RIGHT EXTENSIONS. POST-OP, EFFECTIVE RIGHT SIDE THERAPY WAS ACHIEVED. THE DOCTOR PLANS TO REPLACE THE FRACTURED, LEFT LEAD ON A LATER DATE. AT THIS TIME THE FRACTURED, LEFT LEAD AND THE REPLACEMENT LEFT EXTENSION ARE NOT CONNECTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
403936	QUATTRODE	DBS LEAD	GZB	ST. JUDE MEDICAL - NEUROMODULATION	6147	3913643

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other	DBS IPG, MODEL: 6644\| IMPLANT DATE: