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

Model Number SC-2218-50

Device Problems Bent (1059); Break (1069); Fracture (1260); High impedance (1291); Kinked (1339); Device Or Device Fragments Location Unknown (2590); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Undesired Nerve Stimulation (1980); Inadequate Pain Relief (2388)

Event Date 06/21/2017

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model#: sc-1110-02, serial#: (b)(4), description: precision implantable pulse generator (ipg).Model#: sc-2218-50, serial#: (b)(4), description: linear st lead, 50cm.Model#: sc-4316, serial#: (b)(4), description: next generation anchor kit-sterile.

Event Description

A report was received that the patient was experiencing loss in stimulation sensation with unpleasant stimulation occurring at the thoracic level.The physician assessed that the contacts were out of range with suspicion that the leads are broken at the click anchor site.

Manufacturer Narrative

Additional information was received that the patient will undergo a surgical procedure to assess the status of the leads.

Event Description

A report was received that the patient was experiencing loss in stimulation sensation with unpleasant stimulation occurring at the thoracic level.The physician assessed that the contacts were out of range with suspicion that the leads are broken at the click anchor site.

Manufacturer Narrative

Sc-2218-50 (b)(4): lead the complaint has been confirmed.Visual (microscope) and x-ray inspection of the lead revealed that all of the cables were completely broken at the bent/kinked location of the lead.The bent/kinked location is 1 cm from the set screw mark of the clik anchor.There are no exposed cables at the fracture location.The broken cables resulted in the reported complaint of high impedance.Sc-2218-50 (b)(4): lead 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 1 cm from the set screw mark of the clik anchor.There are no exposed cables at the clik site fracture locations.The broken cables resulted in the reported complaint of high impedance.Sc-4316: clik anchor the eyelets were torn, and silicone materials from the eyelets were missing.The physician has confirmed that nothing remained inside the patients body.

Event Description

A report was received that the patient was experiencing loss in stimulation sensation with unpleasant stimulation occurring at the thoracic level.The physician assessed that the contacts were out of range with suspicion that the leads are broken at the click anchor site.

Manufacturer Narrative

Additional information was received that the patient underwent an explant procedure wherein the two leads and clik anchors were explanted.The physician noted there were high impedances on the leads, and he assessed that two leads were fractured.The physician chose to leave the ipg implanted in the patient.

Event Description

A report was received that the patient was experiencing loss in stimulation sensation with unpleasant stimulation occurring at the thoracic level.The physician assessed that the contacts were out of range with suspicion that the leads are broken at the click anchor site.

• 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: 6710696
• MDR Text Key: 79939054
• Report Number: 3006630150-2017-02411
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767725
• UDI-Public: (01)08714729767725(17)180317(10)19038700
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: 30017
• 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,Followup
• Report Date: 01/24/2018

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: 03/17/2018
• Device Model Number: SC-2218-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2017
• Initial Date FDA Received: 07/13/2017
• Supplement Dates Manufacturer Received: 07/18/2017; 11/24/2017; 01/08/2018
• Supplement Dates FDA Received: 08/08/2017; 12/11/2017; 01/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 51 YR