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

Model Number SC-8216-50

Device Problem Material Separation (1562)

Patient Problems Discomfort (2330); Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)

Event Date 01/18/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

A report was received that during patient's explant procedure, one of the contacts from the paddle lead came off and was left inside the patient.

Manufacturer Narrative

Additional information was received that the physician has no next course of action regarding the contact that remained in the patient.

Event Description

A report was received that during patient's explant procedure, one of the contacts from the paddle lead came off and was left inside the patient.

Manufacturer Narrative

Device evaluation indicated that the electrode # 8 is missing from the paddle.In addition, the lead was cut, and two tails were not returned.

Event Description

A report was received that during patient's explant procedure, one of the contacts from the paddle lead came off and was left inside the patient.

Manufacturer Narrative

Additional information was received that the patient had ipg discomfort and inadequate stimulation.

Event Description

A report was received that during patient's explant procedure, one of the contacts from the paddle lead came off and was left inside the patient.

Manufacturer Narrative

Additional information received that the patient had ipg discomfort and inadequate stimulation.There will be no further course of action.

Event Description

A report was received that during patient's explant procedure, one of the contacts from the paddle lead came off and was left inside the patient.

• 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: 5397595
• MDR Text Key: 37058135
• Report Number: 3006630150-2016-00154
• 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: 01/18/2016

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: 02/29/2016
• Device Model Number: SC-8216-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2016
• Initial Date FDA Received: 01/28/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/10/2016; 05/01/2016; 09/01/2016; 09/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2014
• 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: 75 YR