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

Model Number SC-8336-50

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A report was received that the patient experienced loss of stimulation.An imaging was taken and showed signs of the lead possibly bending and the contacts had fallen of.It was determined that the lead was ripped into several pieces and was no longer working.The lead was replaced and the patient was reportedly doing well postoperatively.

Manufacturer Narrative

Additional information was received that everything was explanted from the patient including the missing electrode and 32 contact lead.Sc-8336-50/1071277 device evaluation indicated that the paddle lead ripped inside the patient's body as confirmed by rep's submitted images.The visual inspection of the paddle lead revealed that silicon was torn and one section is missing.In addition, the cables near the paddle were pulled and exposed.X-ray inspection found that 19 out of 32 electrodes are missing from the paddle.

Event Description

A report was received that the patient experienced loss of stimulation.An imaging was taken and showed signs of the lead possibly bending and the contacts had fallen of.It was determined that the lead was ripped into several pieces and was no longer working.The lead was replaced and the patient was reportedly doing well postoperatively.

• Brand Name: PRECISION SPECTRA®
• 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: 5707925
• MDR Text Key: 46852993
• Report Number: 3006630150-2016-01463
• 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: 05/12/2016

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2017
• Device Model Number: SC-8336-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2016
• Initial Date FDA Received: 06/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2015
• 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): Required Intervention
• Patient Age: 62 YR