MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INJEX¿; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	97792
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from manufacturer's representative regarding an implantable component.It was reported that a shaving came off the new anchor as it was put on the sterile field.They will be sending the anchor in for analysis.The healthcare provider used another anchor during the implant.No symptoms or further complications reported.
Additional Manufacturer Narrative
Analysis results were not available at the time of this report.A follow up will be sent when analysis is completed.Additional review indicated conclusion code is no longer applicable to the event.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis of the anchor lot# n759234 found foreign material in the stimulation packaging/accessory kit.Conclusion code 11 no longer applies.Product analysis #702235493: analysis information -- (b)(4) 2018 17:58:47 cst pli# 10 product id# 97792 below is unedited, system generated text based on the analysis finding code(s) and test results.A material analysis was performed.{the foreign material was determined to be polyisoprene which is not the same material as the silicone anchor.There was also an ester glue like material on the bonded side of the fm (see the chem tech report).The origin of the fm is unknown.If information is provided in the future, a supplemental report will be issued.

• Brand Name: INJEX¿
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 7097443
• Report Number: 2182207-2017-00005
• Device Sequence Number: 901405
• Product Code: LGW
• UDI-Device Identifier: 00643169023215
• UDI-Public: 00643169023215
• 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
• Report Date (Section B): 02/19/2018

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: 10/10/2021
• Device Model Number: 97792
• Device Catalogue Number: 97792
• Device Lot Number: N759234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 12/11/2017; 01/25/2018
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 12/13/2017; 02/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1