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

Model Number SC-2316-50

Device Problems Bent (1059); Fracture (1260); Kinked (1339); Low impedance (2285)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 07/07/2015

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model #: sc-2316-50, serial #: (b)(4), description: infinion 1x16 perc lead kit-50 cm.Model #: sc-1132, serial #: (b)(4)description: precision spectra implantable pulse generator.Model #: sc-3400-30, serial #: (b)(4), description: infinion splitter 2x8 kit (30cm).

Event Description

A report was received that the patient was experiencing a shocking sensation from the stimulator.Database analysis showed low impedances on several contacts of the leads in all ports.An x-ray was taken and revealed that the leads, splitters and the ipg connection all looked good.The patient underwent a revision procedure wherein the leads, splitters and the ipg were replaced.

Manufacturer Narrative

Sc-1132 (sn (b)(4)) the source of the complaint of the stimulation anomalies was verified to be the spectra ipg.With a load of 375 ohms on each electrode, the measured impedances were extremely low (16-30 ohm range).It was determined that the vh node was shorted with the case node (44 ohms).As a result of the damage, the device was depositing excessive charge on the output as soon as the stimulation is turned on.Since these nodes are commonly shared by u2 and u3, and their traces are hidden under the circuit board layers, the exact location of the short cannot be determined.Sc-2316-50 (sn (b)(4)) the lead was cleanly cut during the explant procedure.The clean cut damage is a result of a typical explant procedure and it is not considered a failure.Additionally, six cables were fractured at the bent/kinked sections of the lead body, 1 cm from the clik anchor set screw mark.No cables were exposed.Sc-2316-50 ((b)(4)) the lead was cleanly cut during the explant procedure.X-ray inspection found that the cables were all intact.Damage to the lead is a result of a typical explant procedure and it is not considered a failure.Sc-3400-30 ((b)(4)) visual/x-ray inspections and impedance test were performed to ensure the device integrity.No anomalies were found.

Event Description

A report was received that the patient was experiencing a shocking sensation from the stimulator.Database analysis showed low impedances on several contacts of the leads in all ports.An x-ray was taken and revealed that the leads, splitters and the ipg connection all looked good.The patient underwent a revision procedure wherein the leads, splitters and the ipg 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: 5214060
• MDR Text Key: 30878366
• Report Number: 3006630150-2015-02850
• 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: 07/14/2015

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: 10/31/2015
• Device Model Number: SC-2316-50
• Other Device ID Number: M365SC2316500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2015
• Initial Date FDA Received: 11/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2013
• 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: 66 YR