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 No Known Impact Or Consequence To Patient (2692)

Event Date 05/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.

Event Description

A report was received that during a revision procedure, it was noted that one of the contacts of the lead was lost.X-ray was taken and the lost contact was not inside the patient's body.It was unknown if the contact disappeared on or before the surgery.The lead was placed back to where it was.The patient was doing well postoperatively.

Event Description

A report was received that during a revision procedure, it was noted that one of the contacts of the lead was lost.X-ray was taken and the lost contact was not inside the patient's body.It was unknown if the contact disappeared on or before the surgery.The lead was placed back to where it was.The patient was doing well postoperatively.

Manufacturer Narrative

Additional information was received that the patient underwent a revision procedure to replace the lead with a missing contact.Replacement was per physician's preference.The patient was doing well postoperatively.

Event Description

A report was received that during a revision procedure, it was noted that one of the contacts of the lead was lost.X-ray was taken and the lost contact was not inside the patient's body.It was unknown if the contact disappeared on or before the surgery.The lead was placed back to where it was.The patient was doing well postoperatively.

Manufacturer Narrative

Additional information was received that the patient underwent a revision procedure to replace the lead.Fluoroscopy showed that there were contacts missing on the lead.Replacement was per physician's preference.The patient was doing well postoperatively.

Event Description

A report was received that during a revision procedure, it was noted that one of the contacts of the lead was lost.X-ray was taken and the lost contact was not inside the patient's body.It was unknown if the contact disappeared on or before the surgery.The lead was placed back to where it was.The patient was doing well postoperatively.

Manufacturer Narrative

Device evaluation indicated that the complaint has been confirmed.Three electrodes were dislodged and missing (e#8, 24, and 32).One cable was fractured (e16).The associated cables were exposed as the bare cables were pulled out of the paddle.The cause of the electrode dislodgement could not be determined.Review of the device history record revealed no anomalies.

Event Description

A report was received that during a revision procedure, it was noted that one of the contacts of the lead was lost.X-ray was taken and the lost contact was not inside the patient's body.It was unknown if the contact disappeared on or before the surgery.The lead was placed back to where it was.The patient 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: 5712677
• MDR Text Key: 47083073
• Report Number: 3006630150-2016-01474
• Device Sequence Number: 1
• Product Code: LGW
• 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,Followup,Followup
• Report Date: 05/06/2016

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: 03/23/2018
• Device Model Number: SC-8336-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2016
• Initial Date FDA Received: 06/09/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/07/2016; 08/10/2016; 08/18/2016; 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2016
• 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: 37 YR