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

Model Number SC-2317-50

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

Patient Problems Device Overstimulation of Tissue (1991); Inadequate Pain Relief (2388)

Event Date 01/19/2017

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model#: sc-1132, serial#: (b)(4), description: precision spectra implantable pulse generator.Model#: sc-2317-50, serial#: (b)(4), description: infiniontm cx 50 cm lead.Model#: sc-4316, lot#: 18390607, description: next generation anchor kit-sterile.

Event Description

A report was received that the patient was experiencing inadequate stimulation.High impedances were noted.X-ray result confirmed that the lead was kinked.The physician suspected that the lead was fractured which caused the patient being shocked when turning on the device.The patient underwent a revision procedure wherein the ipg, leads, and clik anchor were replaced.

Manufacturer Narrative

Additional information was received that the patient was doing well postoperatively.The explanted devices were not returned to bsn as they were discarded by the medical facility.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 was experiencing inadequate stimulation.High impedances were noted.X-ray result confirmed that the lead was kinked.The physician suspected that the lead was fractured which caused the patient being shocked when turning on the device.The patient underwent a revision procedure wherein the ipg, leads, and clik anchor were replaced.

• 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: 6313992
• MDR Text Key: 66915931
• Report Number: 3006630150-2017-00412
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729861614
• UDI-Public: (01)08714729861614(17)170713(10)18189971
• 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: 01/19/2017

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: 07/13/2017
• Device Model Number: SC-2317-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2017
• Initial Date FDA Received: 02/09/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2015
• 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