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

Model Number SC-2158-70

Device Problems Bent (1059); Fracture (1260); High impedance (1291); Kinked (1339); Migration or Expulsion of Device (1395)

Patient Problem Inadequate Pain Relief (2388)

Event Date 04/12/2017

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model#: sc-2158-70 serial#: (b)(4) description: linear lead with enhanced stylet, 70cm model#: sc-4318 lot#: 19872195 description: clik x anchor.

Event Description

A report was received that the patient was experiencing lost of coverage.It was also reported that the leads had migrated and a lead was having four contacts out.The patient underwent a revision procedure wherein two leads and click anchors were replaced.Device malfunction was suspected.The patient was reportedly doing well postoperatively.

Manufacturer Narrative

Sc-2158-70 sn: (b)(4) device evaluation indicated that the lead passed all tests performed.Sc-2158-70 sn:(b)(4) device evaluation indicated that the complaint has been confirmed.Visual (microscope) and x-ray inspection of the lead revealed that multiple cables were completely broken at the bent/kinked location of the lead.The bent/kinked location is 3 cm from the set screw mark of the clik x anchor.There are no exposed cables at the clik site fracture locations.The broken cables resulted in the reported complaint of high impedance.

Event Description

A report was received that the patient was experiencing lost of coverage.It was also reported that the leads had migrated and a lead was having four contacts out.The patient underwent a revision procedure wherein two leads and click anchors were replaced.Device malfunction was suspected.The patient was reportedly doing well postoperatively.

• 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: 6583469
• MDR Text Key: 75719902
• Report Number: 3006630150-2017-01850
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767718
• UDI-Public: (01)08714729767718(17)170831(10)18258329
• 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: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2017
• Device Model Number: SC-2158-70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2017
• Initial Date FDA Received: 05/22/2017
• Supplement Dates Manufacturer Received: 08/18/2017
• Supplement Dates FDA Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2015
• 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: 45 YR