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

Model Number SC-2218-30

Device Problems Break (1069); Material Separation (1562)

Patient Problems Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)

Event Date 09/02/2017

Event Type  Injury  

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-2352-50, serial #: (b)(4), description: linear 3-4 lead 50cm.Model #: sc-1132, serial #: (b)(4), description: precision spectra implantable pulse generator.

Event Description

A report was received that the patient underwent a lead explant procedure, wherein three leads and the ipg were removed for an unknown reason.During the procedure, one of the leads was discovered to have been broken inside of the patient.The proximal to contacts broke off the lead and could not be removed from the patient.

Manufacturer Narrative

Additional information was received that the patient underwent the revision procedure due to no longer achieving adequate stimulation with their current lead configuration.Only one lead was explanted and replaced, though it is unknown which of the patient's implanted leads was removed.The ipg was not explanted.

Event Description

A report was received that the patient underwent a lead explant procedure, wherein three leads and the ipg were removed for an unknown reason.During the procedure, one of the leads was discovered to have been broken inside of the patient.The proximal to contacts broke off the lead and could not be removed from the patient.

Manufacturer Narrative

Lead sc-2218-30 (b)(4): as the device involved in the complaint has not been returned, the complaint investigation site (cis) could not perform a device analysis.However a review of the complaint report and device history record did not find any anomalies or deviations that potentially relate to the reported event; there is no reason to suspect a manufacturing defect as the source of the reported complaint.Lead sc-2316-50 (b)(4): visual inspection revealed lead was cleanly cut approximately 42 inches from the distal end.X-ray inspection of the lead revealed that five of the cables were completely broken at the bent/kinked location of the lead.The bent/kinked locations are 1 cm from both sides of the set screw mark of the clik anchor.No cables are exposed at the fracture site.The clean cut damage is a result of a typical explant procedure and it is not considered a failure.Lead sc-2352-50 (b)(4): visual inspection revealed that the lead was cleanly cut approximately 44 cm from the tip of distal end.There are no exposed cables.X-ray inspection found no cable breakage.Damage to the device is a result of a typical explant procedure and it is not considered a failure.Lead splitter sc-3400-30 sn 667966: visual inspection revealed that the lead was cleanly cut approximately 22 cm from the connector of the lead.The damage to the lead is consistent with damages done during the explant procedure and are not considered a failure.

Event Description

A report was received that the patient underwent a lead explant procedure, wherein three leads and the ipg were removed for an unknown reason.During the procedure, one of the leads was discovered to have been broken inside of the patient.The proximal to contacts broke off the lead and could not be removed from the patient.

• 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: 6878972
• MDR Text Key: 86746017
• Report Number: 3006630150-2017-03465
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729771180
• UDI-Public: 08714729771180
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: 030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2017

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: 02/26/2016
• Device Model Number: SC-2218-30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2017
• Initial Date FDA Received: 09/20/2017
• Supplement Dates Manufacturer Received: 09/02/2017; 10/06/2017
• Supplement Dates FDA Received: 09/28/2017; 10/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2014
• 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