FDA Adverse Event Injury Summary report: N

PRECISION®

MDR report key: 5728192 · Received June 15, 2016

Report

Report Number: 3006630150-2016-01533
Event Type: Injury
Date Received: June 15, 2016
Date of Event: May 18, 2016
Report Date: May 18, 2016
Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION
Product Code: LGW
PMA / PMN Number: 030017
Report Source: Manufacturer report
Reporter Location: SC, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

SC-1110-02 (SN (B)(4)) CURRENT LEAKAGE TESTS VERIFIED NO LOSS OF ELECTRIC CURRENT INTO THE SURROUNDING TISSUE. RESIDUAL GAS ANALYSIS VERIFIED THAT THE DEVICE INSULATION WAS NOT COMPROMISED. REVIEW OF THE STERILIZATION RECORD DID NOT FIND ANY ANOMALIES OR DEVIATIONS THAT POTENTIALLY RELATE TO THE REPORTED EVENT. THE DEVICE PASSED THE REQUIRED TESTS AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. SC-8120-70 (SN (B)(4)) VISUAL INSPECTION OF THE LEAD FOUND NO ANOMALIES. REVIEW OF THE STERILIZATION RECORD DID NOT FIND ANY ANOMALIES OR DEVIATIONS THAT POTENTIALLY RELATE TO THE REPORTED EVENT.

Additional Manufacturer Narrative · 1

(B)(4) ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-8120-70 SERIAL #: (B)(4) DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
380858	PRECISION®	SPINAL CORD STIMULATOR	LGW	BOSTON SCIENTIFIC NEUROMODULATION	SC-1110-02	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR		Required Intervention