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

Model Number SC-1110-02

Device Problem Telemetry Discrepancy (1629)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/18/2015

Event Type  Injury  

Manufacturer Narrative

Section is populated with the di number.

Event Description

A report was received that the patient's telemetry does not work and seemed to be spotty.It was noted that the patient could not lean back in chair due to the location of the ipg was very poor for it pushes on the patient's left rib when she leaned back.The patient will undergo a revision procedure wherein the lead and the ipg will be replaced.

Manufacturer Narrative

Additional information was received that the patient had discomfort at the pocket site resulting to replacement of the ipg during a full system revision procedure.The new ipg was relocated as well.Device malfunction was suspected with the ipg since it would not hold its charge.No device malfunction was suspected with the explanted leads.Additional suspect medical device components involved in the event: model #: sc-2218-50, serial #: (b)(4), description: linear st lead, 50cm.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 patient's telemetry does not work and seemed to be spotty.It was noted that the patient could not lean back in chair due to the location of the ipg was very poor for it pushes on the patient's left rib when she leaned back.The patient will undergo a revision procedure wherein the lead and the ipg 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: 5123780
• MDR Text Key: 27338672
• Report Number: 3006630150-2015-02500
• Device Sequence Number: 1
• Product Code: LGW
• 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: Followup
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2011
• Device Model Number: SC-1110-02
• Other Device ID Number: M365SC1110020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2009
• 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: 52 YR