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

Model Number SC-1110-02

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

Patient Problems Stroke/CVA (1770); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

Date of event: (b)(6) 2015.(b)(4).Additional suspect medical device components involved in the event: model #: sc-2366-50, serial #: (b)(4), description: linear 3-6 lead, 30cm.

Event Description

A report was received that the patient experienced a cerebrovascular accident (cva) and urinary incontinence for six to twelve months.The patient underwent an explant procedure and was stable post-operatively.The physician assessed the events to be device related.

Event Description

A report was received that the patient experienced a cerebrovascular accident (cva) and urinary incontinence for six to twelve months.The patient underwent an explant procedure and was stable post-operatively.The physician assessed the events to be device related.

Manufacturer Narrative

The cause of cerebrovascular accident (cva) and urinary incontinence could not be determined.Sc-1110-02, s/n (b)(4): the header was contaminated with human blood.However, it did not affect lead connection with the electrodes.The device passed the functional test and it revealed no anomalies.Sc-2366-30, s/n (b)(4): e4 was fractured in the electrode array of the distal end on both leads.There are no exposed cables on either leads.

Event Description

A report was received that the patient experienced a cerebrovascular accident (cva) and urinary incontinence for six to twelve months.The patient underwent an explant procedure and was stable post-operatively.The physician assessed the events to be device related.

Manufacturer Narrative

Device analysis.The cause of cerebrovascular accident (cva), urinary incontinence, and cable fracture could not be determined.Sc-1110-02 s/n (b)(4): visual inspection revealed that the header was contaminated with human blood.However, it did not affect lead connection with the electrodes.The stimulation signal was monitored on an oscilloscope and it was observed that the outputs were consistent and correct on all electrodes.Current leakage tests verified no loss of electric current into the surrounding tissue.Residual gas analysis verified that the device insulation was not compromised.The device passed the functional tests and revealed no anomalies.Sc-2366-30 s/n (b)(4): device passed visual inspection.X-ray inspection revealed that electrode #4 cable was fractured in the electrode array of the distal end.There are no exposed cables.Impedance test confirmed that electrode #4 is open.Sc-2366-30 s/n (b)(4): device passed visual inspection.X-ray inspection revealed that electrode #8 cable was fractured in the electrode array of the distal end.There are no exposed cables.Impedance test confirmed that electrode #8 is open.

Event Description

A report was received that the patient experienced a cerebrovascular accident (cva) and urinary incontinence for six to twelve months.The patient underwent an explant procedure and was stable post-operatively.The physician assessed the events to be device related.

• 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: 5642135
• MDR Text Key: 44775962
• Report Number: 3006630150-2016-01116
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: 030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2012
• Device Model Number: SC-1110-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2016
• Initial Date FDA Received: 05/09/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 06/03/2016; 06/22/2016; 08/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2010
• 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): Hospitalization; Required Intervention