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

Model Number SC-2316-50

Device Problems Fracture (1260); High impedance (1291); Failure to Align (2522)

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

Event Date 06/14/2017

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) model #: sc-1132 serial #: (b)(4) description: precision spectra implantable pulse generator.

Event Description

A report was received that the patient had high impedances.During revision procedure, the physician had difficulty aligning the lead with the ipg and one of the lead was stuck in the ipg.Lead fracture was suspected.The patient underwent a revision procedure wherein the ipg, leads, and splitters were replaced.The patient was doing well postoperatively.

Manufacturer Narrative

Additional information was received that the patient was no longer felt stimulation or relief as a result of high impedances.The returned ipg ((b)(4)), clik anchor ((b)(4)), and lead splitter (sc-3400-30/(b)(4)) were analyzed and no anomalies were found.Sc-2316-50 (sn:(b)(4)) device evaluation indicated that the complaint has been confirmed.Visual inspection found lead body was bent/kinked/damaged at the clik anchor site, 1 cm from the set screw mark.The fracture location is 24 cm from the distal end.X-ray inspection confirmed all cables were fractured.There are no exposed cables at the clik site fracture.The fractured cables resulted in the reported high impedances.Sc-2316-50 (sn:(b)(4)) device evaluation indicated that the complaint has been confirmed.Visual inspection found lead body was bent/kinked/damaged at the clik anchor site, 1 cm from the set screw mark.The fracture location is 24 cm from the distal end.X-ray inspection confirmed all cables were fractured.There are no exposed cables at the clik site fracture.Additionally, visual inspection revealed that the lead body has a pulled and exposed cable at the midsection.The fractured cables resulted in the reported high impedances.

Event Description

A report was received that the patient had high impedances.During revision procedure, the physician had difficulty aligning the lead with the ipg and one of the lead was stuck in the ipg.Lead fracture was suspected.The patient underwent a revision procedure wherein the ipg, 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: 6802688
• MDR Text Key: 82987756
• Report Number: 3006630150-2017-03039
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729797814
• UDI-Public: 08714729797814
• 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: 07/31/2017

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: 08/03/2019
• Device Model Number: SC-2316-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2017
• Initial Date FDA Received: 08/17/2017
• Supplement Dates Manufacturer Received: 09/06/2017
• Supplement Dates FDA Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2015
• 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 Age: 55 YR