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

Model Number SC-2316-70

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/28/2017

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: model#: sc-2316-70 serial #: (b)(4), description: infinion 70 cm lead kit.

Event Description

A report was received that during the patient¿s scheduled lead pull, one of the leads broke and several of the contacts remained in the patient¿s body.It was noted that the physician will remove the broken lead on the patient¿s permanent implant procedure.

Manufacturer Narrative

Sc-2316-70 (sn: (b)(4)) device evaluation indicated that the reported complaint states that while explanting the trial leads, one of them broke and electrodes 1 to 8 were completely separated from the distal end.The distal array was fractured.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 is 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.The insulation of some of the cables has 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 indicates 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.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.Sc-2316-70 (sn: (b)(4)) device evaluation indicated that the visual inspection revealed that lead was cleanly cut at 12cm from distal end and no cables are exposed.The proximal end along with the residual lead was not returned.The clean cut damage is a result of a typical explant procedure and it is not considered a failure.

Event Description

A report was received that during the patient¿s scheduled lead pull, one of the leads broke and several of the contacts remained in the patient¿s body.It was noted that the physician will remove the broken lead on the patient¿s permanent implant procedure.

• Brand Name: PRECISION MONTAGE MRI
• 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: 6864591
• MDR Text Key: 86114946
• Report Number: 3006630150-2017-03500
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729797821
• UDI-Public: 08714729797821
• 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: 08/28/2017

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: 11/29/2018
• Device Model Number: SC-2316-70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2017
• Initial Date FDA Received: 09/14/2017
• Supplement Dates Manufacturer Received: 10/05/2017
• Supplement Dates FDA Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2016
• 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: 48 YR