MAUDE Adverse Event Report: PRECISION SPECTRA; SPINAL CORD STIMULATION

Model Number	SC-9208-15E
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model#: sc-9208-15e, serial#: (b)(4) description: scs s8 adapter trial, 15cm.
Event or Problem Description
A report was received that during the patients implant procedure high impedances were noted on the patients lead when the connectors were used.It was noted that one tail of the lead was shredded.The patient underwent a lead replacement procedure and was doing well postoperatively.
Additional Manufacturer Narrative
Additional information was received that the lead that was shredded and had high impedance was a competitive device.Due to the condition of the competitive product, the physician opted to replace it with a bsc product.S8 connectors were returned as they were opened but were not used.The physician confirmed that there was nothing wrong with the bsc products.
Event or Problem Description
A report was received that during the patients implant procedure high impedances were noted on the patients lead when the connectors were used.It was noted that one tail of the lead was shredded.The patient underwent a lead replacement procedure and was doing well postoperatively.

• Brand Name: PRECISION SPECTRA
• Common Device Name: SPINAL CORD STIMULATION
• MDR Report Key: 7110503
• Report Number: 3006630150-2017-05264
• Device Sequence Number: 13775539
• Product Code: LGW
• UDI-Device Identifier: 08714729893295
• UDI-Public: 08714729893295
• Combination Product (Y/N): N
• PMA/510(K) Number: 030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/03/2017
• Device Model Number: SC-9208-15E
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/17/2017
• Supplement Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR