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

Model Number SC-8352-70

Device Problems Fracture (1260); High impedance (1291); Material Separation (1562); Component Missing (2306)

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

Event Date 10/25/2017

Event Type  Injury  

Event Description

A report was received that the patients lead was broken.It was mentioned that the lead came out the epidural space and one of the contacts was having high impedance.The patient underwent a lead replacement procedure.No device malfunction was suspected.The patient was doing well postoperatively.

Manufacturer Narrative

Sc-8352-70 (b)(4) device evaluation indicated that the complaint was confirmed.Visual inspection revealed that electrode #16 was dislodged and it was missing.Cable #16 was exposed.Additional visual inspection revealed the silicone where the paddle end met the four pigtails was damaged/torn.The damage was caused by excessive tensile force being exerted against the silicone material.Review of the device history record revealed no anomalies.Sc-4316 (ln 19964238) device evaluation indicated that both clik anchors passed all the required tests and revealed no anomalies.

Event Description

A report was received that the patients lead was broken.It was mentioned that the lead came out the epidural space and one of the contacts was having high impedance.The patient underwent a lead replacement procedure.No device malfunction was suspected.The patient was doing well postoperatively.

Manufacturer Narrative

Additional information was received that everything was removed from the patients body.

Event Description

A report was received that the patients lead was broken.It was mentioned that the lead came out the epidural space and one of the contacts was having high impedance.The patient underwent a lead replacement procedure.No device malfunction was suspected.The patient was doing well postoperatively.

• Brand Name: SPECTRA WAVEWRITER
• 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: 7026582
• MDR Text Key: 91876866
• Report Number: 3006630150-2017-04525
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729832690
• UDI-Public: 08714729832690
• 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
• Report Date: 01/08/2018

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: 05/22/2019
• Device Model Number: SC-8352-70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 11/13/2017
• Supplement Dates Manufacturer Received: 11/28/2017; 12/19/2017
• Supplement Dates FDA Received: 12/15/2017; 01/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2017
• 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: 30 YR