PRECISION®

Report

Report Number: 3006630150-2012-02287
Event Type: Injury
Date Received: December 12, 2012
Date of Event: November 19, 2012
Report Date: November 24, 2012
Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION
Product Code: LGW
PMA / PMN Number: 030017
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAS AN ALLERGY WITH TITANIUM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

Additional Manufacturer Narrative · 1

ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-70, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD 70 CM; MODEL #: SC-4316, LOT #: 15526998, DESCRIPTION: CLIK ANCHOR.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT WAS HOSPITALIZED DUE TO A SUSPECTED INFECTION. THE PATIENT HAD PAIN, REDNESS, SWELLING, FEVER AND CHILLS BUT NO DRAINAGE AT THE INCISION SITES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE PHYSICIAN BELIEVED THAT THERE WAS NO INFECTION. NO ANTIBIOTICS WERE PRESCRIBED. THE PATIENT WAS SENT TO AN ALLERGY SPECIALIST TO ASSESS ALLERGY FOR TITANIUM.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT WAS HOSPITALIZED DUE TO A SUSPECTED INFECTION. THE PATIENT HAD PAIN, REDNESS, SWELLING, FEVER AND CHILLS BUT NO DRAINAGE AT THE INCISION SITES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE PHYSICIAN BELIEVED THAT THERE WAS NO INFECTION. NO ANTIBIOTICS WERE PRESCRIBED. THE PATIENT WAS SENT TO AN ALLERGY SPECIALIST TO ASSESS ALLERGY FOR TITANIUM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PRECISION®	SPINAL CORD STIMULATOR	LGW	BOSTON SCIENTIFIC NEUROMODULATION	SC-1110-02	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR		Hospitalization\| R