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

Model Number SC-2316-50

Device Problems Bent (1059); Fracture (1260); High impedance (1291); Kinked (1339); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/09/2015

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-3400-30, serial #: (b)(4), description: infinion splitter 2x8 kit (30 cm).

Event Description

A report was received that all contacts of the patient's leads had high impedances.The patient underwent a revision procedure wherein the leads were replaced and the splitters were explanted.Malfunction was suspected because only one contact was working.The patient was doing well postoperatively.

Manufacturer Narrative

The complaint was confirmed.Both infinion leads exhibited cable fractures.Sc-2316-50/(b)(4): all cables were fractured at the bent/kinked section of the lead body.Fractures were located at the clik anchor site, 1 cm from the set screw mark.Sc-2316-50/(b)(4): six cables were fractured in the electrode array of the proximal end.In addition, one of the cables was fractured near the retention sleeve.Sc-3400-30/(b)(4): visual/x-ray inspections and impedance test were performed to ensure the device integrity.No anomalies were found.Sc-4316: one of the clik anchors was missing silicon eyelets.Additional information was received that the eyelet was not left inside the patient's body.

Event Description

A report was received that all contacts of the patient's leads had high impedances.The patient underwent a revision procedure wherein the leads were replaced and the splitters were explanted.Malfunction was suspected because only one contact was working.The patient was 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: 5256179
• MDR Text Key: 32342607
• Report Number: 3006630150-2015-03097
• 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: 11/09/2015

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: 09/14/2015
• Device Model Number: SC-2316-50
• Other Device ID Number: M365SC2316500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2015
• Initial Date FDA Received: 11/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2014
• 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: 60 YR