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)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/03/2017

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device component involved in the event: model#: sc-2316-50 serial #: (b)(4) description:infinion 1x16 perc lead kit-50 cm.

Event Description

A report was received that the patient's left lead had full of impedances resulting to patient of not getting coverage on the left side.The patient will undergo a revision procedure wherein the leads will be replaced.

Manufacturer Narrative

Additional information was received that the patient underwent a revision procedure wherein the leads and lead splitters were replaced.The patient was doing well postoperatively.Additional suspect medical device components involved in the event: model #: sc-3400-30, serial #: (b)(4), description: infinion splitter 2x8 kit (30 cm).Model #: sc-2316-50e, serial #: (b)(4), description: infinion 1x16 perc lead and splitter 2x8 kits.

Event Description

A report was received that the patient's left lead had full of impedances resulting to patient of not getting coverage on the left side.The patient will undergo a revision procedure wherein the leads will be replaced.

Manufacturer Narrative

Additional suspect medical device component involved in the event: model#: sc-4316 lot #: 18182693 description: next generation anchor kit-sterile.

Event Description

A report was received that the patient's left lead had full of impedances resulting to patient of not getting coverage on the left side.The patient will undergo a revision procedure wherein the leads will be replaced.

Manufacturer Narrative

Sc-2316-50 (sn:(b)(4)) device evaluation indicated that the lead body was bent/kinked/damaged at the clik anchor site, 1 cm from the set screw mark.The fracture location was 22 cm from the distal end.X-ray inspection confirmed all cables but one were fractured.There were no exposed cables at the clik site fracture.The fractured cables resulted in loss of stimulation and high impedances at the left side of patient¿s body.Additionally, visual inspection revealed that the lead was cleanly cut at 26 cm from distal end.The clean cut damage was a result of a typical explant procedure and it was not considered a failure.Sc-2316-50 (sn:9b)(4)) device evaluation indicated that the source of the complaint in regard to the high impedance was verified to be with the associated lead.Visual inspection revealed that the lead was cleanly cut at 29 cm from distal end.X-ray inspections found no cable breakage.The clean cut damage was a result of a typical explant procedure and it was not considered a failure.Sc-3400-30 (sn:(b)(4)) device evaluation indicated that the device passed all tests performed.Sc-4316 (ln:18182693) device evaluation indicated that the eyelet was torn, and there was no missing silicone material.

Event Description

A report was received that the patient's left lead had full of impedances resulting to patient of not getting coverage on the left side.The patient will undergo a revision procedure wherein the leads will be 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: 6274938
• MDR Text Key: 65666196
• Report Number: 3006630150-2017-00207
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729797814
• UDI-Public: (01)08714729797814(17)170506(10)17941830
• 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,Followup,Followup
• Report Date: 01/03/2017

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: 05/06/2017
• Device Model Number: SC-2316-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2017
• Initial Date FDA Received: 01/24/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/27/2017; 03/07/2017; 03/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2015
• 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: 50 YR