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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Unexpected Therapeutic Results (1631); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Electric Shock (2554)

Event Date 05/24/2017

Event Type  Injury  

Manufacturer Narrative

Other application components are: product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2015, product type: lead.Product id: 977a260, serial#: (b)(4), implanted: (b)(6) 2015, product type: lead.

Event Description

Information was received from a consumer via a manufacturing representative regarding a patient who implanted with a nuerostimulator for non-malignant pain and failed back surgery syndrome.It was reported that the patient had a lack of pain relief and occasional jolting from the device.The representative ran impedances at 0.7, 1.5, and 3v and at all levels only 2,3,4,5 electrodes were below 10, 20, and 40k respectively.At 3,0v, 0,7 and 10 electrodes were high but still under 40k.The representative tried reprogramming but the event remains unresolved.No further complications were reported as a result of this event.

Manufacturer Narrative

The event date is unknown.***information regarding the out of range impedances were previously captured in manufacturer¿s report # 3004209178-2017-01435.Any further information regarding this event will now be captured in this manufacturer's report.*** if information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative on 2016-12-28 which reported that electrodes 12 and 15 were out of range, so the manufacturer representative reprogrammed with other electrodes, and the issue was resolved at the time of the report on 2016-12-28.Additional information was received from a consumer regarding the patient on 2017-06-02.It was reported that there was no stimulation and shocking.The patient has never gotten the same coverage with the permanent implant that he did during his trial.He doesn¿t use the device often because it is not effective.He met with a manufacturer representative roughly three or four months prior to the report (confirmed as 2017) who indicated that a couple of contacts weren¿t functioning and there was no impedance.There were discussions around possible replacement of the lead or relocating it.More recently (late (b)(4) 2017) after he charged the implant and turned it on, there was no stimulation.He tried changing the settings, but there was still nothing.The following day when he was walking down the stairs, he felt a jolt in the left side.He turned down the settings.On the day of the report when he moved a little to the right, he got it again (a pretty hard shock).The patient met with a manufacturer representative on 2017-06-12 regarding the lack of pain relief and occasional jolting which had started about 3 weeks prior to the report.There was no relevant event that led up to the change per the patient.Impedances were run at 0.7 volts, 1.5 volts, and 3 volts and at all levels, only electrodes 2, 3, 4, and 5 were below 10,000 ohms, 20,000 ohms, and 40.000 ohms; respectively.At 3.0 volts, electrodes 0, 7, and 10 also came in high, but under 40,000 ohms.The health care provider had discussed surgery with the patient after reprogramming the patient to the remaining electrodes.After reprogramming the active electrodes, the coverage was in the right area of his body.The issue was not resolved at the time of the report.A surgery was planned, but not yet scheduled, and no further actions had yet been taken to resolve the issue.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6641368
• MDR Text Key: 77621074
• Report Number: 3004209178-2017-12905
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2017
• Date Device Manufactured: 04/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 98