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

Model Number	37022
Medical Device Problem Codes	Low impedance (2285); Impedance Problem (2950)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	05/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other applicable components are: product id: 977d260, lot# va1gsxj045, product type: screening device.Product id: 977d260, lot# va1ffmw014, product type: screening device.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer¿s representative (rep) regarding a trial patient with an external neurostimulator (ens).The rep reported that there was an out of regulation (oor) code seen.The rep reported that they were in the middle of a trial with 2 leads and seeing oor on two different ens¿s.The rep reported that they were using evolve programming (90 pulsewidth, 1,000 rate) and when they increased to 3.4v they saw oor.The rep reported that all impedances were in range and everything appeared to be connected.The rep reported that they changed the batteries in the ens but still saw oor before they programmed anything.The rep reported that the patient was sore on their left side.The rep reported that they then switched clinician programmers and was able to initiate programmer with 90 pulsewidth.One thousand (1,000) rate on electrodes 5 and 6 but as soon as they increased voltage to 3.7v they saw oor.The rep decreased rate to 500 and was able to increase to 5v before seeing oor.The rep reported that they then went back to 4.3v and changed rate to 1,000 and was able to program this ok.The rep checked impedance values at 3.0v and out of range values were 4-5, 4-6, 4-7, and 5-6 which were all less than 150 ohms.The rep reported that with reference 0-15 all were less than 1,000 ohms but with reference 4, contacts 5, 6, and 7 were showing less than 150 ohms.The rep reported that the other lead was fine/not showing oor.Additional information was received from the rep on 2017-05-22.The rep reported that the patient was programmed around the oor related impedance.The rep reported that the oor and low impedances had not been resolved.The rep reported that the patient¿s soreness had resolved.No further complications were reported.

• Brand Name: RESTORE
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 6633161
• Report Number: 2182208-2017-01017
• Device Sequence Number: 7152
• Product Code: LGW
• UDI-Device Identifier: 00613994972286
• UDI-Public: 00613994972286
• 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
• Report Date (Section B): 06/12/2017

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 Model Number: 37022
• Device Catalogue Number: 37022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2017
• Initial Report FDA Received Date: 06/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1