MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-9218-55
Medical Device Problem Codes	High impedance (1291); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); No Code Available (3191)
Date of Event	01/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A report was received that the patient was experiencing ineffective therapy and underwent a lead explant procedure due to high impedances found during troubleshooting.After the lead was explanted, it was found that during charging, the issue was resolved.
Additional Manufacturer Narrative
Analysis of sc-9218-55 (serial number: (b)(4)) confirmed the complaint of high impedance.Visual inspection revealed the cable connected to contact #2 had torn off.X-ray inspection confirmed the fractured cable.The breakage of the cable is consistent with lead damage due to excessive tensile force.The probable cause code is unintended use error caused or contributed to event.
Event or Problem Description
A report was received that the patient was experiencing ineffective therapy and underwent a lead explant procedure due to high impedances found during troubleshooting.After the lead was explanted, it was found that during charging, the issue was resolved.

• Brand Name: PRECISION
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 8322758
• Report Number: 3006630150-2019-00459
• Device Sequence Number: 1527562
• Product Code: LGW
• UDI-Device Identifier: 08714729888758
• UDI-Public: 08714729888758
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

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: 03/14/2019
• Device Model Number: SC-9218-55
• Device Catalogue Number: SC-9218-55
• Device Lot Number: 20380082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 03/18/2019
• 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