MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION INTERSTIM; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number	355018
Medical Device Problem Code	Shelf Life Exceeded (1567)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: 3531, serial# unknown, product type: external neurostimulator; product id: 3889-28, lot# va1dvxc, implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: lead.This event was also reported under manufacturer report #3007566237-2018-01029.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative (rep) regarding a test patient during an intraoperative procedure.It was reported that a surgeon was doing a case for a pediatric surgeon at a hospital that all hcps knew to be off label.The lead was placed in the patient and all items were opened by the charge nurse.Everything was placed without an event however prior to closing, the charge nurse pointed out that the lead was expired and so the lead was pulled and a new lead was placed successfully.Once the case was over, the charge nurse pointed out that they had made an error and it wasn¿t the lead that was expired but rather the lead introducer kit was expired.It was stressed again by the rep that the lead placed in the body was never expired.It was reported the patient was fine and the issue was resolved at the time of the report.There were no further complications reported/anticipated.On 2018-mar-28, additional information was received from a manufacturer representative (rep).It was reported the physician was aware of the event and that they didn't require any follow up.On 2018-april-03, additional information was received from the rep.It was reported that there was not a neurostimulator (ins) involved as the procedure was a test, the therapy was unsuccessful and has been pulled already.The representative reported that the lead introducer kit was a product of the hospital where the procedure took place and that the explanted lead was discarded.There were no further complications reported/anticipated.

• Brand Name: INTERSTIM
• Common Device Name: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421
• MDR Report Key: 7429483
• Report Number: 3007566237-2018-01087
• Device Sequence Number: 11253528
• Product Code: GZB
• UDI-Device Identifier: 00613994729989
• UDI-Public: 00613994729989
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• 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
• Report Date (Section B): 04/13/2018

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: Health Professional
• Device Expiration Date: 03/03/2018
• Device Model Number: 355018
• Device Catalogue Number: 355018
• Device Lot Number: W60298
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 04/13/2018
• 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
• Patient Age: 8 YR