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

Model Number SC-1110-02

Device Problems High impedance (1291); Telemetry Discrepancy (1629)

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

Event Date 12/20/2016

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model#: sc-2218-50, serial #: (b)(4), description: linear st lead, 50cm.

Event Description

A report was received that the patient had telemetry issues.It was noted that the patient¿s lead was non-functional and it was having high impedances.The patient will undergo a revision procedure wherein the ipg and a lead will be replaced.

Manufacturer Narrative

Additional information was received that the patient underwent an ipg and leads replacement procedure.

Event Description

A report was received that the patient had telemetry issues.It was noted that the patient¿s lead was non-functional and it was having high impedances.The patient will undergo a revision procedure wherein the ipg and a lead will be replaced.

Manufacturer Narrative

Additional information was received that device malfunction was suspected.

Event Description

A report was received that the patient had telemetry issues.It was noted that the patient¿s lead was non-functional and it was having high impedances.The patient will undergo a revision procedure wherein the ipg and a lead will be replaced.

Manufacturer Narrative

Additional information was received that there was no device malfunction suspected for the explanted ipg.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 had telemetry issues.It was noted that the patient¿s lead was non-functional and it was having high impedances.The patient will undergo a revision procedure wherein the ipg and a lead will be replaced.

• Brand Name: PRECISION®
• 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: 6214513
• MDR Text Key: 63611312
• Report Number: 3006630150-2016-03925
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767688
• UDI-Public: (01)08714729767688(17)150401(10)15980564
• 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,Followup
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2015
• Device Model Number: SC-1110-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2013
• 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: 35 YR