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); Purulent Discharge (1812); Fever (1858); Pain (1994); Respiratory Distress (2045); Swelling (2091)

Event Date 02/02/2017

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model #: sc-1132 serial #: (b)(4) description: precision spectra implantable pulse generator.Model #: sc-8352-50 serial #: (b)(4) description: coveredge x 32, 50 cm 4x8 surgical lead.Model #: sc-8216-50 serial #: (b)(4) description: artisan surgical lead, 50 cm model #: sc-4316 lot #: 19964237 description: next generation anchor kit-sterile.The explanted devices were not returned to bsn as they were kept 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.

Event Description

A report was received that the patient was experiencing severe pain at the ipg site, fever, and shortness of breath.The patient was prescribed clindamycin for cellulitis at the ipg site.It was noted that both incision sites were painful, hot to touch, red, and swollen.The patient underwent an explant procedure.The physician did not know the cause of infection and suspected something else from the incision or from the procedure.The patient was doing well postoperatively.

Manufacturer Narrative

Additional information was received that during the explant procedure on (b)(6) 2017, the patient's ipg pocket was explored and an incisional irrigation and debridement was performed due to the presence of pus.During the (b)(6) 2017 explant procedure lead sites were irrigated, debrided and cleaned.One of the leads was cut due to its entirety being firmly adherent to the thecal sac.

Event Description

A report was received that the patient was experiencing severe pain at the ipg site, fever, and shortness of breath.The patient was prescribed clindamycin for cellulitis at the ipg site.It was noted that both incision sites were painful, hot to touch, red, and swollen.The patient underwent two explant procedures.During the first procedure on (b)(6) 2017, one ipg was explanted.On (b)(6) 2017, the remaining devices were also explanted.The physician did not know the cause of infection and suspected something else from the incision or from the procedure.The patient was doing well post-operatively.

Manufacturer Narrative

Additional information was received that the patient developed an infection in his epidural spine running up his spinal cord stimulator.

Event Description

A report was received that the patient was experiencing severe pain at the ipg site, fever, and shortness of breath.The patient was prescribed clindamycin for cellulitis at the ipg site.It was noted that both incision sites were painful, hot to touch, red, and swollen.The patient underwent two explant procedures.During the first procedure on (b)(6) 2017, one ipg was explanted.On (b)(6) 2017, the remaining devices were then explanted due to tuberculosis.The physician did not know the cause of infection and suspected something else from the incision or from the procedure.The patient was doing well post-operatively.

• 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: 6372827
• MDR Text Key: 68826303
• Report Number: 3006630150-2017-00651
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729821526
• UDI-Public: (01)08714729821526(17)181010(10)19809834
• 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: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/10/2018
• Device Model Number: SC-1132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2016
• 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: 48 YR