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

Model Number SC-2316-70

Device Problems Bent (1059); Break (1069); Fracture (1260); High impedance (1291); Kinked (1339)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional suspect medical device components involved in the event: model#: sc-2316-50 serial#: (b)(4) description: infinion1x16 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 the patient has several contacts on both leads that were measuring high impedances.Database analysis on impedance measurements revealed eleven contacts with high values on port ab.The patient underwent a revision procedure wherein the leads and splitters were replaced.The patient was doing well postoperatively.

Manufacturer Narrative

(b)(4).Device evaluation indicated that the complaint had been 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 is 1 cm from the set screw mark of the clik anchor.There were no exposed cables at the clik site fracture locations.The broken cables resulted in the reported complaint of high impedance.Sc-2316-70, (b)(4): device evaluation indicated that the complaint had been confirmed.Impedance tests confirmed the complaint.High impedance readings were registered at contacts 6 and 11.External visual inspection of the lead found that the lead proximal end was fractured between contacts # 10 and 11.X-ray inspection revealed broken cables located between contacts number 10 and 11.No cables were exposed at the fracture site.The dhr review found no anomalies when the lead was manufactured.(b)(4): device evaluation indicated that the complaint was not verified.A test infinion lead was inserted into the splitter connector without any anomalies.Device exhibited normal device characteristics.

Event Description

A report was received that the patient has several contacts on both leads that were measuring high impedances.Database analysis on impedance measurements revealed eleven contacts with high values on port ab.The patient underwent a revision procedure wherein the leads and splitters were replaced.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: 5461877
• MDR Text Key: 39079081
• Report Number: 3006630150-2016-00408
• 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: 01/07/2016

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: 06/30/2014
• Device Model Number: SC-2316-70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2016
• Initial Date FDA Received: 02/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2012
• 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: 36 YR