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

Model Number	3708240
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer representative (rep) regarding a patient who was implanted with an implantable neurosti mulator (ins) for chronic low back pain and radiculopathy.It was reported that the the rep found out that several years ago the original ins was replaced by a competing manufacturer's ins and connected to our extension and lead.Case was scheduled for normal end of life replacement.Upon x-rays in the or, we saw that extension was fractured.Removed extension and when disconnecting from lead the wires were starting to fray when pulling out of the extension. unable to connect new extension to existing lead as the lead wire was damaged. the healthcare provider (hcp) removed entire system and will schedule patient to come back at a future date for a full implant with a 2/8 surgical paddle lead.The issue was resolved.

• Brand Name: NA
• 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: 11359234
• Report Number: 2182207-2021-00289
• Device Sequence Number: 16783090
• Product Code: LGW
• UDI-Device Identifier: 00885074404516
• UDI-Public: 00885074404516
• 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
• Device Implanted Year: 2007
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2021

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: 01/05/2011
• Device Model Number: 3708240
• Device Catalogue Number: 3708240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 02/22/2021
• 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