FDA Adverse Event Injury Summary report: N

LAMITRODE TRIPOLE 16

MDR report key: 3142123 · Received May 28, 2013

Report

Report Number: 1627487-2013-04628
Event Type: Injury
Date Received: May 28, 2013
Date of Event: April 30, 2013
Report Date: April 30, 2013
Manufacturer: ST JUDE MEDICAL - NEUROMODULATION
Product Code: LGW
PMA / PMN Number: P010032
Adverse Event: 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 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 2. REF MFR REPORT: 1627487-2013-04674. IT WAS REPORTED THE PT HAD LOSS OF STIMULATION COVERAGE AND SHE HAD FALLEN. THE PHYSICIAN DETERMINED THE PT'S LEAD HAD MIGRATED. FOLLOW UP IDENTIFIED THE PHYSICIAN UNDERTOOK SURGICAL INTERVENTION AND IT WAS REPORTED THE LEAD WAS REPOSITIONED AND BURIED DEEPER UNDER THE SKIN. IN ADDITION, DURING THE PROCEDURE THE PHYSICIAN OPTED TO REPOSITION THE IPG TO A NEW LOCATION. IT WAS REPORTED THE PT HAD COMMUNICATION ISSUES DUE TO THE WAY THE IPG WAS POSITIONED IN THE BODY. FOLLOW UP IDENTIFIED THE PT RECEIVED EFFECTIVE STIMULATION POSTOPERATIVE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
233244	LAMITRODE TRIPOLE 16	SCS LEAD	LGW	ST JUDE MEDICAL - NEUROMODULATION	3219	3428651

Patients

Seq	Age	Sex	Outcome	Treatment
1	56 YR		Required Intervention