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

Model Number	3986A
Medical Device Problem Code	Device Or Device Fragments Location Unknown (2590)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant devices: product id 37701, serial# (b)(4), implanted: (b)(6) 2006, product type: implantable neurostimulator.
Event or Problem Description
Information was received from a healthcare provider (hcp) regarding a patient who was implanted with an implantable neurostimulator (ins) for radicular pain syndrome (radiculopathies).The hcp reported that the ins was removed but the leads/electrodes remained implanted.The hcp didn¿t have any further information at the time.The hcp reported that the patient thought the ins was explanted in 2012.Additional information was received from the patient stating that they decided to have device and lead removed due to device continuously moving and lodging itselft against the spine.No further complications reported.

• Brand Name: RESUME TL
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• MDR Report Key: 6777210
• Report Number: 3007566237-2017-03218
• Device Sequence Number: 188119
• Product Code: LGW
• UDI-Device Identifier: 00673978926438
• UDI-Public: 00673978926438
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/09/2017

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: 08/24/2009
• Device Model Number: 3986A
• Device Catalogue Number: 3986A
• Device Lot Number: N0042436
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 08/09/2017
• 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