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

Model Number	SC-3138-35
Medical Device Problem Codes	Break (1069); High impedance (1291); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	01/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model #: sc-1110-02, serial # (b)(4), description: precision implantable pulse generator (ipg).
Event or Problem Description
A report was received that the patient experienced a loss of stimulation due to high impedances.The patient underwent a revision procedure wherein it was discovered that the patient's extension was broken and completely disconnected from the ipg.There were exposed cables on the extension.The patient's ipg was also flipped.The extension was replaced and the patient's ipg was revised.
Additional Manufacturer Narrative
Lead extension sc-3138-35 sn (b)(4): the compliant was confirmed.The lead body was completely separated from the connector.It appears that excessive tensile force was exerted onto the lead body and it resulted in its separation from the connector.A review of the manufacturing documentation for the lead extension and ipg revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.
Event or Problem Description
A report was received that the patient experienced a loss of stimulation due to high impedances.The patient underwent a revision procedure wherein it was discovered that the patient's extension was broken and completely disconnected from the ipg.There were exposed cables on the extension.The patient's ipg was also flipped.The extension was replaced and the patient's ipg was revised.

• Brand Name: PRECISION
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 6287197
• Report Number: 3006630150-2017-00208
• Device Sequence Number: 10946983
• Product Code: LGW
• UDI-Device Identifier: 08714729760566
• UDI-Public: (01)08714729760566(17)170109(10)150601
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: 030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2017

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/22/2017
• Device Model Number: SC-3138-35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2017
• Supplement Report FDA Received Date: 04/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention