MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	97714
Medical Device Problem Codes	Failure to Deliver Energy (1211); High impedance (1291)
Health Effect - Clinical Codes	Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Information references the main component of the system and other applicable components are: product id 97714, serial# (b)(4), product type implantable neurostimulator.
Event or Problem Description
Information was received via a manufacturing representative (rep) regarding a patient who was implanted with a neurostimulator (ins) for spinal pain.Information was reported that a patient was not able to feel paranesthesia anymore due to her lead having all high impedances.The patient had a lead revision.Patient only had one lead and the doctor pulled that lead out of the patient's body a placed another lead.The reason for explanting the lead was due to the impedances were all high and the patient was not able to feel any paranesthesia no matter what amplitude.No further complications were reported.No additional patient symptoms were reported.
Additional Manufacturer Narrative
The correct manufacturing id is (b)(4).Concomitant products: product id: 977a275, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2017, product type: lead.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from a rep.It was reported that all of the electrodes showed high and the patient was not able to feel stimulation.The reason the electrodes showed high impedance was undetermined.No patient symptoms or complications were reported in this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from the patient and a manufacture representative reported that the patient did not feel any stimulation on any groups/configurations.The rep checked the ins and found that all electrodes had high impedances.No further complications were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from the representative.It was reported that the cause was not determined, the patient reported that they didn't fall or anything.They tried to reprogram the patient but were unable to feel any stimulation.The issue wasn't resolved and the representative told them that they needed to have a lead revision but the patient didn't want to do anything right now.No further complications reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 7026359
• Report Number: 2649622-2017-12856
• Device Sequence Number: 1275759
• Product Code: LGW
• UDI-Device Identifier: 00643169109384
• UDI-Public: 00643169109384
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2017
• Supplement Date Received by Manufacturer: 11/20/2017; 07/23/2018; 07/24/2018; 08/08/2018
• Initial Report FDA Received Date: 11/13/2017
• Supplement Report FDA Received Date: 12/01/2017; 07/24/2018; 08/02/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention