FDA Adverse Event Injury Summary report: N

EON MINI

MDR report key: 3950536 · Received July 10, 2014

Report

Report Number: 1627487-2014-12462
Event Type: Injury
Date Received: July 10, 2014
Date of Event: June 1, 2014
Report Date: June 12, 2014
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

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 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 2. REF MFR REPORT #1627487-2014-12463. IT WAS REPORTED THAT PT'S IPG AND LEAD SITES WERE PAINFUL. ON (B)(6) 2014, THE PT WENT TO THE EMERGENCY ROOM AND WAS ADMITTED TO THE HOSP AND THE PT RECEIVED IV ANTIBIOTICS. CULTURES WERE TAKEN, RESULTS ARE UNK. THE PHYSICIAN PRESCRIBED A TEN DAY COURSE OF ANTIBIOTIC ON (B)(6) 2014. AT THAT TIME TH IPG SITE INCISION WAS HEALED, BUT THE LEAD SITE WAS STILL OPEN. THE PT WILL FOLLOW UP WITH THE PHYSICIAN IN A WEEK AS THE NEXT COURSE OF ACTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
403871	EON MINI	SCS IPG	GZB	ST. JUDE MEDICAL - NEUROMODULATION	3788	4434290

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR		Hospitalization	IMPLANT DATE\| SCS ANCHOR, MODEL 1194\| SCS EXTENSION, MODEL 3383\| IMPLANT DATE