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

Model Number SC-2316-50E

Device Problems Break (1069); Fracture (1260); Material Separation (1562)

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

Event Date 07/21/2017

Event Type  Injury  

Manufacturer Narrative

Sc-2316-50e (sn: (b)(4)) device evaluation indicated that the distal array was fractured.Electrodes 1 to 7 were completely separated from the distal end.Electrodes #1 to 7 were not returned.Visual inspection of the fractured cables revealed fraying of the breaks, lack of necking and discoloration associated with welding, and the proximity of the break points to the edge of the insulation indicate that the cables didn't break at or near the welds.The breaks cannot be attributed to the quality of the welding.The ablated multilumen was torn.The distal half of the ablated section of the multilumen was ripped off.It takes at least a couple pounds of tension to cause this type of damage.Cable # 10 can be seen exiting the last intact electrode (#11).Damage suggests that the multilumen was stretched out.There were gaps between the pellethane and the electrode on either side of the electrode.It takes a few pounds of tensile force to break the adhesion and create such a gap on a lead.The insulation of some of the cables had been stripped.If the weld was severed, the insulation wouldn¿t be stripped away.Scraping the insulation away requires exposure to sufficient force.All of the available evidence indicated that the lead was subject to an excessive tensile load.The morphology also matches the appearance of other leads that were known to break under excessive tensile loading.Sc-2316-50e (sn: (b)(4)) device evaluation indicated that the lead passed all tests performed.

Event Description

A report was received that during the patient¿s scheduled lead pull, seven contacts came off while the leads were being pulled out.It was noted that the contacts were left inside the patient¿s body.The patient will undergo a permanent implant procedure and the said contacts will also be removed at that time.

Manufacturer Narrative

Additional information was received that the physician opted not to take out the remaining contacts in the patient¿s body during the permanent implant procedure.No further course of action will be taken.

Event Description

A report was received that during the patient¿s scheduled lead pull, seven contacts came off while the leads were being pulled out.It was noted that the contacts were left inside the patient¿s body.The patient will undergo a permanent implant procedure and the said contacts will also be removed at that time.

• 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: 6792573
• MDR Text Key: 82652251
• Report Number: 3006630150-2017-02926
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729797807
• UDI-Public: 08714729797807
• 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: 07/21/2017

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/09/2019
• Device Model Number: SC-2316-50E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2017
• Initial Date FDA Received: 08/14/2017
• Supplement Dates Manufacturer Received: 09/29/2017
• Supplement Dates FDA Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2017
• 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: 79 YR