FDA Adverse Event Injury Summary report: N

PRECISION®

MDR report key: 3833992 · Received May 27, 2014

Report

Report Number: 3006630150-2014-01200
Event Type: Injury
Date Received: May 27, 2014
Date of Event: May 6, 2014
Report Date: May 6, 2014
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

ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS ALSO EXPERIENCING PAIN AT THE MIDLINE SITE. THE PATIENT UNDERWENT A REVISION WHEREIN THE IPG WAS MOVED DEEPER. THE PATIENT WAS DOING WELL POST-OPERATIVELY. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION WAS RECEIVED THAT DURING THE REVISION, THE SUTURE SLEEVE WAS ALSO IMPLANTED DEEPER. THE LEADS WERE NOT MOVED.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING PAIN AT THE POCKET SITE. THE PHYSICIAN BELIEVED THAT THE DEVICE MAY BE SITTING ON A NERVE. THE PATIENT WILL UNDERGO A POCKET REVISION PROCEDURE.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING PAIN AT THE POCKET SITE. THE PHYSICIAN BELIEVED THAT THE DEVICE MAY BE SITTING ON A NERVE. THE PATIENT WILL UNDERGO A POCKET REVISION PROCEDURE.

Description of Event or Problem · 1

A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING PAIN AT THE POCKET SITE. THE PHYSICIAN BELIEVED THAT THE DEVICE MAY BE SITTING ON A NERVE. THE PATIENT WILL UNDERGO A POCKET REVISION PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
310591	PRECISION®	SPINAL CORD STIMULATOR	LGW	BOSTON SCIENTIFIC NEUROMODULATION	SC-1110-02	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	43 YR		Required Intervention