FDA Adverse Event Injury Summary report: N

PENTA

MDR report key: 2922005 · Received January 4, 2013

Report

Report Number: 1627487-2013-02023
Event Type: Injury
Date Received: January 4, 2013
Date of Event: December 11, 2012
Report Date: December 11, 2012
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION
Product Code: GZB
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 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

THE PATIENT UNDERWENT SURGERY FOR A PERMANENT SCS SYSTEM FOR LEFT-SIDED LOW BACK, LEG AND FOOT PAIN. IT WAS REPORTED THE PHYSICIAN HAD SOME DIFFICULTY WITH INTRAOPERATIVE LEAD PLACEMENT BUT WAS EVENTUALLY ABLE TO PLACE THE LEAD WHERE HE WANTED. THE PATIENT REPORTED SEVERE ABDOMINAL PAIN POSTOPERATIVE THAT SEEMED TO START ON THE LEFT SIDE. THE ABDOMINAL PAIN ALLEGEDLY WAS UNCHANGED WHETHER STIMULATION WAS ON OR OFF. THE PATIENT ALSO REPORTED AN INABILITY TO URINATE POSTOPERATIVE. SHE WAS TREATED WITH INTRAVENOUS PAIN MEDICATION AND RECEIVED A URINARY CATHETER IN THE HOSPITAL. FOLLOW-UP INDICATED THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012 AND REPORTED A SIGNIFICANT IMPROVEMENT IN HER SYMPTOMS. HER SCS SYSTEM REMAINS IMPLANTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
5470	PENTA	SCS LEAD	GZB	ST. JUDE MEDICAL - NEUROMODULATION	3228	3835941

Patients

Seq	Age	Sex	Outcome	Treatment
1	42 YR		Hospitalization\| R	SCS IPG: MODEL 3788\| IMPLANT DATE: