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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); No Device Output (1435); Device Difficult to Program or Calibrate (1496); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Therapeutic Effects, Unexpected (2099); Malaise (2359)

Event Date 11/01/2015

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: pnma01411a004, serial# unknown, product type: recharger.

Event Description

Information was received from a patient who was implanted with a neurostimulator for non-malignant pain.The patient reported poor coupling with recharging.Since (b)(6) 2017 the patient¿s implantable neurostimulator recharger (insr) and patient programmer would not turn on the stimulator.The patient initially stated that their stimulation just turns off and they feel nothing.The patient is unable to turn the stimulation back on and their stimulator will not hold a charge.On the day of the report the patient stated that while charging their system there were 0 coupling bars showing and the implantable neurostimulator (ins) battery was blinking at the 25% mark.The patient tried using their patient programmer but it would not let them get to where they can even program it.The patient mentioned that since (b)(6) 2015 their belt does not provide good coupling.The patient stated that their use spanks because ¿the belt is stupid¿ and the belt was never going to work for them.The patient stated that they were charging right over the skin and tried switching from a sitting position to a lying position which gave the patient 4 bars.It was unknown if troubleshooting resolved the issue.The patient stated that they were only getting 4 bars after switching positions but would continue to work with it since they normally charge lying down anyway.The patient stated that they had not kept up with charging due to an unrelated surgery and they were not feeling good.The patient normally charges every night.The patient confirmed that the problem with the patient programmer was that they were not able to turn stimulation on using it, but it was reviewed with the patient that the ins automatically turns off when it is less than 25% full.It was reviewed with the patient to charge their ins back to at least 25% in order to turn the stimulation back on.No further complications were reported/are anticipated.

Manufacturer Narrative

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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6453254
• MDR Text Key: 71503916
• Report Number: 3004209178-2017-06852
• Device Sequence Number: 1
• Product Code: LGW
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2017
• Date Device Manufactured: 08/24/2015
• 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 Age: 56 YR