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

Model Number SC-8336-50

Device Problems Circuit Failure (1089); Material Separation (1562); Device Inoperable (1663)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device component involved in the event: model #: sc-1132 serial #: (b)(4), description: precision spectra implantable pulse generator.

Event Description

A report was received that the patient was experiencing lack of stimulation due to the paddle lead no longer functioning and was not fully intact.The physician believed that the ipg might have shorted out with the lead.The patient underwent an ipg and lead replacement procedure.Device malfunction was suspected.The patient was doing well postoperatively.

Manufacturer Narrative

Sc-8336-50 (sn (b)(4)) device evaluation indicated that the complaint could not be investigated due to incomplete device return.The lead bodies were cleanly cut and the paddle was not returned.The clean cut damage is a result of a typical explant procedure and it is not considered a failure.Sc-1132 (sn (b)(4)) device evaluation indicated that the complaint could not be investigated due to complete device damage after the explant procedure.The device would not be charged nor linked due to damaged u2_asic.The device sleep current was extremely excessive (22.2 ma).Vh to ground was short (244 ohm).The patient data was captured using an external power source.The device had been normal prior to the explant procedure, suggesting the device damage was damaged during the procedure.

Event Description

A report was received that the patient was experiencing lack of stimulation due to the paddle lead no longer functioning and was not fully intact.The physician believed that the ipg might have shorted out with the lead.The patient underwent an ipg and lead replacement procedure.Device malfunction was suspected.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: 7598302
• MDR Text Key: 111012541
• Report Number: 3006630150-2018-02123
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729832669
• UDI-Public: 08714729832669
• 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: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/11/2018
• Device Model Number: SC-8336-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/13/2018
• Supplement Dates Manufacturer Received: 07/01/2018
• Supplement Dates FDA Received: 07/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2016
• 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 Age: 54 YR