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

Model Number SC-8336-50

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Material Separation (1562); Component Missing (2306)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/11/2017

Event Type  Injury  

Event Description

A report was received that the patient was experiencing loss of stimulation.X-ray results showed that the lead had migrated.It was also noted that the lead was damaged at the base of the paddle and contacts were pulled off the lead.The physician was unable to determine the cause of the damage.The patient underwent a lead replacement procedure and was doing well postoperatively.

Manufacturer Narrative

Sc-8336-50 (b)(4) device evaluation indicated that the complaint has been confirmed.Visual inspection revealed that body of the paddle end has been severely damaged and torn apart.There are exposed cables.It appears that excessive tensile force was exerted onto the lead bodies.Electrodes # 8, 31 and 32 are missing.Electrical tests could not be performed due missing electrodes and the extensive damage to the body of lead.The cause of the lead damage could not be determined.

Event Description

A report was received that the patient was experiencing loss of stimulation.X-ray results showed that the lead had migrated.It was also noted that the lead was damaged at the base of the paddle and contacts were pulled off the lead.The physician was unable to determine the cause of the damage.The patient underwent a lead replacement procedure and was doing well postoperatively.

Manufacturer Narrative

Additional information was received that the detached contacts were suctioned out and removed from the patient.

Event Description

A report was received that the patient was experiencing loss of stimulation.X-ray results showed that the lead had migrated.It was also noted that the lead was damaged at the base of the paddle and contacts were pulled off the lead.The physician was unable to determine the cause of the damage.The patient underwent a lead replacement procedure and was 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: 6836737
• MDR Text Key: 84299627
• Report Number: 3006630150-2017-03221
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729832669
• UDI-Public: 08714729832669
• 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,Followup
• Report Date: 08/11/2017

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: 04/08/2019
• Device Model Number: SC-8336-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2017
• Initial Date FDA Received: 08/31/2017
• Supplement Dates Manufacturer Received: 09/11/2017; 09/29/2017
• Supplement Dates FDA Received: 09/27/2017; 10/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2017
• 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: 50 YR