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 Problems Undesired Nerve Stimulation (1980); Inadequate Pain Relief (2388)

Event Date 03/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional suspect medical device component involved in the event: model #: sc-2218-50, (b)(4), description: linear st lead, 50cm it is indicated that the lead (sc-2218-50, (b)(4)) will not be returned for evaluation; therefore a failure analysis of the complaint device 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 and stimulation in non-target areas.High impedances were noted on one of the leads.The patient underwent a revision procedure wherein the lead was replaced.The physician suspected device malfunction with the lead.The patient was reportedly doing well postoperatively.

Manufacturer Narrative

Model: sc-2218-50, (sn (b)(4)): device evaluation indicated that the complaint had been confirmed.Visual (microscope) and x-ray inspection of the lead revealed that 4 cables were fractured at the bent/kinked location of the lead.The bent/kinked location was 1 cm from the set screw mark of the clik anchor.No cables were exposed at the fracture site.

Event Description

A report was received that the patient was experiencing inadequate stimulation and stimulation in non-target areas.High impedances were noted on one of the leads.The patient underwent a revision procedure wherein the lead was replaced.The physician suspected device malfunction with the lead.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: 5583451
• MDR Text Key: 42851270
• Report Number: 3006630150-2016-00930
• 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: 03/21/2016

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: 09/17/2017
• Device Model Number: SC-2218-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2016
• Initial Date FDA Received: 04/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2015
• 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: 45 YR