FDA Adverse Event Injury Summary report: N

SINGLE EXTENSION

MDR report key: 3032086 · Received March 26, 2013

Report

Report Number: 1627487-2013-10099
Event Type: Injury
Date Received: March 26, 2013
Date of Event: December 27, 2012
Report Date: March 5, 2013
Manufacturer: ST JUDE MEDICAL - NEUROMODULATION
Product Code: LGW
PMA / PMN Number: P010032
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SP
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS - THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS AND NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. CONCLUSION - THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 4 OF 5. REF MFR REPORT: 1627487-2013-10096, -10097, -10098 AND -10100. THE PT (SPAIN) HAD AN SCS SYSTEM WHICH INCLUDED THE IPG, TWO LEADS (FROM THE SAME LOT), TWO LEAD EXTENSIONS (FROM DIFFERENT LOTS) AND TWO LEAD ANCHORS (FROM THE SAME LOT). IT WAS REPORTED THE PT WAS HOSPITALIZED DUE TO AN INFECTION. AN ANTIBIOGRAM WAS PERFORMED AND CAME BACK (B)(6). THE PT WAS TREATED WITH ORAL ANTIBIOTICS AND THE ENTIRE SCS SYSTEM WAS EXPLANTED. FURTHER INVESTIGATION IDENTIFIED THE INFECTION HAS SINCE RESOLVED. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO THE MFR FOR ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
124155	SINGLE EXTENSION	SCS LEAD EXTENSION	LGW	ST JUDE MEDICAL - NEUROMODULATION	3386	3796698

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR		Hospitalization\| R