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

Model Number	SC-4275
Medical Device Problem Code	Device Expiration Issue (1216)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The scs spare torque wrench will not be returned to bsn as it was discarded by the medical facility.It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device 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 or Problem Description
A report was received that during an implant procedure an expired scs spare torque wrench was used.There was no harm to the patient.
Event or Problem Description
A report was received that during an implant procedure an expired scs spare torque wrench was used.There was no harm to the patient.

• Brand Name: PRECISION MONTAGE
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 6594600
• Report Number: 3006630150-2017-01976
• Device Sequence Number: 18913207
• Product Code: LGW
• UDI-Device Identifier: 08714729121435
• UDI-Public: (01)08714729121435(17)170228(10)17717852
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: 030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2017

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
• Operator of Device: Physician
• Device Expiration Date: 02/28/2017
• Device Model Number: SC-4275
• Device Lot Number: 17717852
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/04/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 06/16/2017
• 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: Other