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

Model Number SC-2218-50

Device Problems Fracture (1260); High impedance (1291); Kinked (1339)

Patient Problems Inadequate Pain Relief (2388); Shock from Patient Lead(s) (3162)

Event Date 01/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional suspect medical device component involved in the event: model #: sc-2218-50 serial #: (b)(4) description: linear st lead, 50cm.

Event Description

A report was received that the patient was experiencing loss of stimulation, and shocking sensation when turning the stimulation up high.The patient had one lead with all contacts completely out and another lead with two or three contacts working.It was unknown if the leads were disconnected of if there was an actual malfunction.The patient will undergo a revision procedure wherein the leads will be replaced.

Manufacturer Narrative

Additional information was received that the patient underwent a revision procedure wherein the leads were replaced.Device malfunction was suspected.It was noted that there was some kink at the portion of the leads around the clik anchor and lead fracture was also suspected at the site.The patient was doing well postoperatively.The explanted devices were not returned to bsn.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 medwatch will be filed.

Event Description

A report was received that the patient was experiencing loss of stimulation, and shocking sensation when turning the stimulation up high.The patient had one lead with all contacts completely out and another lead with two or three contacts working.It was unknown if the leads were disconnected of if there was an actual malfunction.The patient will undergo a revision procedure wherein the leads will be replaced.

• 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: 5549215
• MDR Text Key: 41938355
• Report Number: 3006630150-2016-00792
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2013
• Device Model Number: SC-2218-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 04/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2011
• 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 Age: 49 YR