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

Model Number SC-2316-50E

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/10/2017

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: model #: sc-2316-50e, serial #: (b)(4), description: infinion 1x16 perc lead and splitter 2x8 kits.

Event Description

A report was received that the trial patient underwent a lead pull.It was noted that during the lead pull one of the leads had four contacts that came off in the subcutaneous area of the patient¿s body.The patient will undergo a permanent implant procedure and will also be explanting the last part of the lead and remaining contacts.

Manufacturer Narrative

Additional information was received that only the contacts were left inside the patients body.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 trial patient underwent a lead pull.It was noted that during the lead pull one of the leads had four contacts that came off in the subcutaneous area of the patient¿s body.The patient will undergo a permanent implant procedure and will also be explanting the last part of the lead and remaining contacts.

Manufacturer Narrative

Additional information was received that there will be no further course of action at this time.

Event Description

A report was received that the trial patient underwent a lead pull.It was noted that during the lead pull one of the leads had four contacts that came off in the subcutaneous area of the patient¿s body.The patient will undergo a permanent implant procedure and will also be explanting the last part of the lead and remaining contacts.

• 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: 6847288
• MDR Text Key: 85079807
• Report Number: 3006630150-2017-03333
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729797807
• UDI-Public: 08714729797807
• 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: 11/30/2017

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: 05/02/2019
• Device Model Number: SC-2316-50E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2017
• Initial Date FDA Received: 09/06/2017
• Supplement Dates Manufacturer Received: 10/06/2017; 11/15/2017
• Supplement Dates FDA Received: 10/23/2017; 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2017
• 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: 57 YR