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

Model Number SC-2218-50

Device Problems Bent (1059); Fracture (1260); Kinked (1339); Migration or Expulsion of Device (1395)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) (sn: (b)(4)) device evaluation indicated that the complaint 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 27 cm from the distal end.Cables were not exposed at the clik anchor fracture site.X-ray inspection confirmed all cables were fractured at the bent/kinked section of the lead.The fractured cables resulted in the reported loss of the stimulation on patient¿s leg.The reported complaint stated that the patient fell and the leads had moved up.The x-rays showed that the leads moved way up too high.The lead was supposed to be located in t7 however the x-rays showed that it was at t5/t6.

Event Description

A report was received that during product analysis it was discovered that the lead was fractured.

• Brand Name: PRECISION
• 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: 6352498
• MDR Text Key: 68110738
• Report Number: 3006630150-2017-00589
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767725
• UDI-Public: (01)08714729767725(17)160720(10)17120565
• 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
• Report Date: 12/13/2016

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: 07/20/2016
• Device Model Number: SC-2218-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2017
• Initial Date FDA Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2014
• 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: 72 YR