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

Model Number SC-8216-70

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Bacterial Infection (1735); Edema (1820); Nerve Damage (1979); Discharge (2225)

Event Date 01/28/2018

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: model#: sc-1132, serial#: (b)(4), description: precision spectra implantable pulse generator.

Event Description

A report was received that the patient developed an infection at the cervical incision site.Symptoms of infection were swelling, discharge and redness.It was believed that the infection was surgical related and device malfunction was not suspected.X-ray result also revealed that the lead was way off to the right and was hitting the nerve roots.The patient was prescribed antibiotics, underwent an explant procedure, and was doing well postoperatively.

Event Description

A report was received that the patient developed an infection at the cervical incision site.Symptoms of infection were swelling, discharge and redness.It was believed that the infection was surgical related and device malfunction was not suspected.X-ray result also revealed that the lead was way off to the right and was hitting the nerve roots.The patient was prescribed antibiotics, underwent an explant procedure, and was doing well postoperatively.

Manufacturer Narrative

Sc-1132 (b)(4) device evaluation indicated that the complaint of abnormal jolting sensation was confirmed.The monitored output of the electrodes confirmed there was unexpected output detected on the e32 as the device was depositing excessive charge on the output.The impedance of the node (e32) was extremely low (0 o) with load connected.The symptom indicated that the electrode was shorted inside the slave asic (u3).In addition, the battery depletion rate measured 63 ua that exceeded the expected range of 50 ua.It was reported that the jolting sensation appeared after the previous revision the patient had, suggesting that the device damaged during procedure.It was reported that electrocautery was used during the patient's lead revision.A review of the complaint report, device history record, and sterilization record were found to be satisfactory and 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-8216-70 (b)(4) device evaluation indicated that the paddle lead was cut during the explant procedure.Review of the complaint report and sterilization record were found to be satisfactory and 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.

Event Description

A report was received that the patient developed an infection at the cervical incision site.Symptoms of infection were swelling, discharge and redness.It was believed that the infection was surgical related and device malfunction was not suspected.X-ray result also revealed that the lead was way off to the right and was hitting the nerve roots.The patient was prescribed antibiotics, underwent an explant 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: 7265718
• MDR Text Key: 99874420
• Report Number: 3006630150-2018-00701
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729779919
• UDI-Public: 08714729779919
• 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: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2018
• Device Model Number: SC-8216-70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2016
• 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: 45 YR