FDA Adverse Event Injury Summary report: N

LAMITRODE S8

MDR report key: 4113046 · Received September 17, 2014

Report

Report Number: 1627487-2014-02656
Event Type: Injury
Date Received: September 17, 2014
Date of Event: August 25, 2014
Report Date: August 25, 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 WERE REVIEWED. 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 2 OF 3. REFERENCE MFR. REPORT: 1627487-2014-02655; 1627487-2014-02657. IT WAS REPORTED DURING THE PATIENT'S POST-OPERATIVE APPOINTMENT, THE PATIENT HAD A FEVER AND SHE COMPLAINED OF SORENESS AT BOTH OF HER SCS IPG AND LEAD SURGICAL INCISION SITES. THE PHYSICIAN REMOVED THE PATIENT'S SUTURES AND PRESCRIBED HER ANTIBIOTICS. ON (B)(6) 2014, THE PATIENT WAS SEEN BY HER PHYSICIAN AND SHE HAD DRAINAGE AT THE IPG SITE. THE PHYSICIAN INSTRUCTED THE PATIENT TO CONTINUE TAKING ANTIBIOTICS AND WOULD SEE HER IN A WEEK TO DETERMINE THE NEXT COURSE OF ACTION. FOLLOW-UP IDENTIFIED THE PATIENT'S SCS SYSTEM WAS REMOVED ON (B)(6) 2014. CULTURES TAKEN WERE POSITIVE FOR (B)(6).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
575274	LAMITRODE S8	SCS LEAD	GZB	ST. JUDE MEDICAL - NEUROMODULATION	3286	4349836

Patients

Seq	Age	Sex	Outcome	Treatment
1	37 YR		Other	IMPLANT DATE:\| SCS ANCHOR: MODEL 1192 (X2)