MAUDE Adverse Event Report: MPRI SPECIFY SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number	977C165
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id: neu_ins_stimulator, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer's representative (rep) regarding an implantable neurostimulator (ins) for the treatment of lumbar radiculopathy and spinal pain.It was reported that the patient was in the operating room and there were high impedances noted.The lead was reset and the issue was still present.The rep stated that they suspected that the set screw was not backed out enough on the ins and may have scraped the lead.A new lead was used and the issue resolved.No further complications were reported or anticipated.No symptoms were reported.
Additional Manufacturer Narrative
Analysis of the lead (b)(4) found no anomalies.Product analysis: analysis information -- 2018-07-24 14:07:54 cst pli# 20 product id# 977c165 below is unedited, system generated text based on the analysis finding code(s) and test results.The returned {device} passed all {functional} testing in the laboratory.No anomalies were identified.Due to the reported complaint, an impedance test was performed in 0.9% saline solution and good impedances were observed using an n'vision clinician programmer.Electrical testing of the lead determined continuity was complete and no electrical shorts were identified between the circuits.Product id: neu_ins_stimulator, serial# unknown, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPECIFY SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 7705411
• Report Number: 2649622-2018-11857
• Device Sequence Number: 16805165
• Product Code: LGW
• UDI-Device Identifier: 00643169464599
• UDI-Public: 00643169464599
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/03/2018

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: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 977C165
• Device Catalogue Number: 977C165
• Device Lot Number: VARNNS015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 07/24/2018; 08/08/2018; 08/08/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 07/24/2018; 10/03/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR