MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION SPECTRA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-1132

Device Problems Fracture (1260); Kinked (1339); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Irritation (1941); Pain (1994); Discomfort (2330); No Code Available (3191)

Event Date 05/23/2017

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model #: sc-2218-50, serial #: (b)(4), description: linear st lead, 50cm; model #: sc-4316, lot #: 16811655/19892086, description: next generation anchor kit-sterile.

Event Description

A report was received that the patient was experiencing pain and irritation due to the stimulator.It was also mentioned that the ipg was causing discomfort to the patient.The patient will undergo an explant procedure.

Manufacturer Narrative

Additional information was received that the patient underwent an explant procedure.The explanted leads and clik anchors were not returned to bsn.It is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint devices could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.

Event Description

A report was received that the patient was experiencing pain and irritation due to the stimulator.It was also mentioned that the ipg was causing discomfort to the patient.The patient will undergo an explant procedure.

Manufacturer Narrative

Sc-1132 (sn: (b)(4)) device evaluation indicated that the device passed all tests performed.Sc-2218 (sn: (b)(4)) device evaluation indicated that the complaint of inadequate stimulation had 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 was 26 cm from the distal end.X-ray inspection confirmed that two cables were fractured.There were no exposed cables at the clik site fracture.The fractured cables resulted in the reported inadequate stimulation.Additionally, visual inspection revealed that the lead was cleanly cut at 23 cm from proximal end.The clean cut damage was a result of a typical explant procedure and it was not considered a failure.Sc-2218 (sn: (b)(4)) device evaluation indicated that visual inspection found lead body was bent/kinked/damaged at the clik anchor site, 1 cm from the set screw mark.The fracture location was 25 cm from the proximal end.X-ray inspections found no cable breakage.Additionally, visual inspection revealed that the lead was cleanly cut at 22 cm from proximal end.The clean cut damage was a result of a typical explant procedure and it was not considered a failure.Sc-4316 device evaluation indicated that the eyelet was torn, and there was no missing silicone material.

Event Description

A report was received that the patient was experiencing pain and irritation due to the stimulator.It was also mentioned that the ipg was causing discomfort to the patient.The patient will undergo an explant procedure.

Event Description

A report was received that the patient was experiencing pain and irritation due to the stimulator.It was also mentioned that the ipg was causing discomfort to the patient.The patient will undergo an explant procedure.

• Brand Name: PRECISION SPECTRA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CLONMEL LIMITED; cashel road; ,; clonmel CA ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; ,; valencia, CA 91355 ; 6619494863
• MDR Report Key: 6635646
• MDR Text Key: 77391426
• Report Number: 3006630150-2017-02172
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729821526
• UDI-Public: (01)08714729821526(17)160602(10)17002147
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030017
• 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: 04/05/2019

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/02/2016
• Device Model Number: SC-1132
• Device Catalogue Number: SC-1132
• Device Lot Number: 17002147
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/31/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2017
• Initial Date FDA Received: 06/12/2017
• Supplement Dates Manufacturer Received: 07/12/2017; 09/08/2017; 04/05/2019
• Supplement Dates FDA Received: 08/02/2017; 09/19/2017; 04/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 75 YR