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

Model Number SC-1132

Device Problem Material Separation (1562)

Patient Problems Bacterial Infection (1735); Purulent Discharge (1812); Unspecified Infection (1930); Weakness (2145)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: model#: sc-8216-70 serial#: (b)(4), description: artisan surgical lead, 70cm.

Event Description

A report was received that the patient developed an infection at the ipg site.Symptoms of yellow green pus, serosanguineous liquid, weakness and tingling in hands were noted.The physician did not know what caused the infection.The patient underwent an explant procedure.In addition, four contacts came off of the paddle during explant.The patient was doing well postoperatively.

Manufacturer Narrative

Additional information was received that the infection was not device or procedure related.The patient was prescribed antibiotics.It was confirmed that everything was taken out from the patients 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.

Event Description

A report was received that the patient developed an infection at the ipg site.Symptoms of yellow green pus, serosanguineous liquid, weakness and tingling in hands were noted.The physician did not know what caused the infection.The patient underwent an explant procedure.In addition, four contacts came off of the paddle during explant.The patient was doing well postoperatively.

• 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: 7304383
• MDR Text Key: 101231261
• Report Number: 3006630150-2018-00850
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729821526
• UDI-Public: 08714729821526
• 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: 03/23/2018

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: 08/03/2017
• Device Model Number: SC-1132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 02/28/2018
• Supplement Dates Manufacturer Received: 03/01/2018
• Supplement Dates FDA Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2015
• 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