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

Model Number SC-1132

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Bacterial Infection (1735)

Event Date 03/26/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 #: (b)(4), description: infinion splitter 2x8 kit (30 cm) model #: sc-4318 lot #: 18388888 description: clik x anchor.

Event Description

A report was received that the patient had infection at the ipg site a month after she was implanted.Infection was not device related.It was also reported that the patient's incisions hurt and the patient felt like the device was coming out of her back but there was no actual skin breakage.The patient had the ipg site drained and was prescribed antibiotics.The patient will undergo an explant procedure.

Manufacturer Narrative

Additional information was received that no further information can be obtained by 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 had infection at the ipg site a month after she was implanted.Infection was not device related.It was also reported that the patient's incisions hurt and the patient felt like the device was coming out of her back but there was no actual skin breakage.The patient had the ipg site drained and was prescribed antibiotics.The patient will undergo an explant procedure.

• 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: 5649123
• MDR Text Key: 44982891
• Report Number: 3006630150-2016-01197
• 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
• Report Date: 04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/19/2018
• Device Model Number: SC-1132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2016
• 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: 55 YR