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

Model Number SC-1132

Device Problems Material Separation (1562); No Apparent Adverse Event (3189)

Patient Problem Pain (1994)

Event Date 09/09/2014

Event Type  Injury  

Event Description

A report was received that the patient was experiencing pain at midline incision and pocket site.The patient will undergo an explant procedure.

Manufacturer Narrative

Additional information was received that it was determined that the lead contacts fell off sometime during the procedure.The physician was not able to see the contacts fall off.However, the contacts was seen through final imaging and the physician was able to remove the contacts.

Event Description

A report was received that the patient was experiencing pain at midline incision and pocket site.The patient will undergo an explant procedure.

Manufacturer Narrative

Additional suspect medical device components involved in the event: model #: sc-8216-50, serial #: (b)(4), description: artisan surgical lead, 50cm; model #: sc-4316, lot #: 16204902, description: next generation anchor kit-sterile.

Event Description

A report was received that the patient was experiencing pain at midline incision and pocket site.The patient will undergo an explant procedure.

Manufacturer Narrative

Additional information was received that the patient underwent an explant procedure.Before closure, the physician found two proximal electrodes from each side of the paddle lead in the patient¿s spinal canal.The two electrodes were removed from the patient¿s body.The explanted devices were not returned to bsn as they were discarded by the medical facility.It is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint devices 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.

• 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: 4133614
• MDR Text Key: 5129234
• Report Number: 3006630150-2014-02237
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2014

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/06/2015
• Device Model Number: SC-1132
• Other Device ID Number: M365SC11320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2014
• Initial Date FDA Received: 10/01/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/22/2014; 12/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2013
• 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: 52 YR