MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION; SPINAL CORD STIMULATOR

Model Number SC-8216-70

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Paralysis (1997); Numbness (2415)

Event Date 12/14/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional suspect medical device components involved in the event: model #: sc-1110-02, serial # (b)(4), description: precision implantable pulse generator (ipg).Model #: sc-8216-70, serial # (b)(4), description: artisan surgical lead, 70cm.Maude event report #mw5060146.It is indicated that the devices will not be returned for evaluation; therefore, a failure analysis of the complaint devices could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.

Event Description

A report was received that the patient experienced numbness in her feet, lips, tongue, neck, eye, right arm, and side.In addition, the patient reported that ever since being implanted she has experienced difficulty walking and other medical issues.The patient reported that the device quit working, her body started worsening, and more than half of her entire body had loss of feeling and can no longer function.The patient was also unable to charge her ipg and felt it was poking underneath her skin.No further information can be obtained.

• Brand Name: PRECISION
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 5585455
• MDR Text Key: 42931338
• Report Number: 3006630150-2016-00822
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: 030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2013
• Device Model Number: SC-8216-70
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR