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

Model Number SC-2218-50

Device Problems Bent (1059); Fracture (1260); High impedance (1291); Kinked (1339)

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/24/2017

Event Type  malfunction  

Manufacturer Narrative

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 due to high impedances.The patient will undergo a revision procedure wherein the leads will be replaced.

Event Description

A report was received that the patient was experiencing loss of stimulation due to high impedances.The patient will undergo a revision procedure wherein the leads will be replaced.

Manufacturer Narrative

Additional information was received that the patient underwent a lead replacement procedure.The patient was doing well postoperatively.

Event Description

A report was received that the patient was experiencing loss of stimulation due to high impedances.The patient will undergo a revision procedure wherein the leads will be replaced.

Manufacturer Narrative

Sc-2218-50 (b)(4) device evaluation indicated that the complaint of high impedances was confirmed.Visual (microscope) and x-ray inspection of the lead revealed that multiple cables were completely broken at the bent/kinked location of the lead.The bent/kinked location was 1cm from the set screw mark of the clik anchor.There were no exposed cables at the clik site fracture locations.The reported complaints of loss of stimulation and high impedances were caused by the fractured cables at the clik anchor site.

Event Description

A report was received that the patient was experiencing loss of stimulation due to high impedances.The patient will undergo a revision procedure wherein the leads will be 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: 6481739
• MDR Text Key: 72420336
• Report Number: 3006630150-2017-01212
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767725
• UDI-Public: (01)08714729767725(17)160227(10)16761019
• 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,Followup,Followup
• Report Date: 02/24/2017

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: 02/27/2016
• Device Model Number: SC-2218-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2017
• Initial Date FDA Received: 04/11/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/09/2017; 06/01/2017; 06/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2014
• 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: 76 YR