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

Model Number SC-1132

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Edema (1820); Hematoma (1884); Impaired Healing (2378)

Event Date 11/08/2016

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model #: sc-2316-50, serial #: (b)(4), description: infinion 1x16 perc lead kit-50 cm.Model #: sc-3400-30, serial #: infinion splitter 2x8 kit (30 cm) description: (b)(4).The explanted devices were not returned to bsn.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.

Event Description

A report was received that the patient was experiencing infection at the pocket site.Symptoms were swelling, hematoma, and healing impairment.The patient was placed on antibiotics and underwent an explant procedure.The physician believed that the infection was device related.

Manufacturer Narrative

Additional information was received that the patient was not healing well.The physician did not know the cause of the hematoma, but it was located in the pocket site.It was believed that the patient's hematoma was not device related.

Event Description

A report was received that the patient was experiencing infection at the pocket site.Symptoms were swelling, hematoma, and healing impairment.The patient was placed on antibiotics and underwent an explant procedure.The physician believed that the infection was device related.

Manufacturer Narrative

Additional information was received that no further information could be obtained.

Event Description

A report was received that the patient was experiencing infection at the pocket site.Symptoms were swelling, hematoma, and healing impairment.The patient was placed on antibiotics and underwent an explant procedure.The physician believed that the infection was device related.

• 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: 6146831
• MDR Text Key: 61490861
• Report Number: 3006630150-2016-03527
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729821526
• UDI-Public: (01)08714729821526(17)180628(10)19418465
• 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: 11/11/2016

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/28/2018
• Device Model Number: SC-1132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/20/2016; 01/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2016
• 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: 62 YR