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

Model Number 97702

Device Problems Premature Discharge of Battery (1057); High impedance (1291); Device Difficult to Program or Calibrate (1496); Unable to Obtain Readings (1516); Low impedance (2285); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 11/20/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer and a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins) for spinal pain.It was reported that the patient saw a doctor icon on the patient programmer but did not know the error message that was with the doctor icon; the patient also indicated that the device had stopped working.The rep reported that the patient's ins had reached end of service (eos) after less than 2 months.An impedance test ran by the healthcare professional (hcp) revealed impedances of 10,000 on electrodes 1 and 3.The rep did not have the programmed parameters to do longevity calculation but stated the hcp would let the rep know how the patient was programmed.Further information received from the rep reported that an elective replacement indicator (eri) message was seen on the physician programmer.Electrode impedance was tested at 3v and revealed out of range impedances at (b)(6):<(><<)>150 ohms; the patient was programmed with a1: 3.8v/450pw/50hz.5+0+11+6-12-2-, group impedance: xxx.Impedance reading were performed using reference 0, 1, 10 and 13.The patient was reprogrammed using electrode 10+14- 450pw/50hz.The rep reported he is not able to increase the voltage and every time he tried to increase, selecting 2v, a message appears to turn stimulation on and an eri message appears.The rep stated that after the message he is only able to increase 0.1v and then reprogrammed again, getting the amplitude up to 0.2v, and it will not allow him to increase to programmed amplitude.The ins battery voltage was checked and was at 2.920v.The rep re-created another group but was still unable to increase to the desired amplitude and is only able to set amplitude at 0.1v each time the hcp attempted to increase the voltage.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a representative.It was reported that the rep was with the patient and tried resetting the ins with a short pmr.The reset did not change the eol status.Rep will discuss replacement with doctor.It was reported that the rep reported the patient had the device failure as reported, end-of-service (eos).It was reported the patient was implanted in october and device had already come to eos.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer representative.It was reported that it was determined that the battery was irrecoverably depleted and needed to be replaced.They were waiting on scheduling and will send the devices in for analysis when available.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.It was reported that the device just quit working, the technician was able to pin point a short in the lead wires and a replacement of everything was recommended.The patient said the surgical replacement took place on (b)(6)2018.No further complications were reported/anticipated.

Manufacturer Narrative

Analysis results not available at the date of this report.A follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Explant date provided.Analysis for product id# 97702 found stim ins/battery/normal end of life/telemetry with no significant anomaly.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURESCAN
• Type of Device: 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
• 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: 7064006
• MDR Text Key: 93767186
• Report Number: 3004209178-2017-24460
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109513
• UDI-Public: 00643169109513
• 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,Followup,Followup
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2019
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2017
• 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: 78 YR
• Patient Weight: 91