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

Model Number 97714

Device Problems Energy Output To Patient Tissue Incorrect (1209); Battery Problem (2885); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Pneumonia (2011); Complaint, Ill-Defined (2331); Malaise (2359); Bronchopneumonia (2437); Sweating (2444)

Event Date 08/29/2016

Event Type  Injury  

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information from representative (rep) was received. It was stated the rep had a very long conversation with a patient today. Rep called patient to return all of devices that was replaced by manufacturer repair department. The patient called rep back today and sent his device back and he was very upset. Patient said he had his device in his back since 2016. Immediately after implant, he became very sick with pneumonia, he said the physician said to turn his device off immediately. He said his previous rep never called him back, he left voice mail message and never received a call back from anyone. He really needed someone to call him immediately and helped him with his situation. He was contacted with another manufacturer and they would send a rep to him immediately to take a statement and look at his device. No further complication and events were reported.

Event Description

Information was received from a manufacturer's representative via a healthcare provider and a consumer regarding an implantable neurostimulator (ins) for the treatment of degenerative disc disorder and spinal pain. It was reported that the patient stated that they feel stimulation in back and legs even though the ins was turned off. The patient has also been ill since 1 week post operation and feels that it is because of the implant. The patient went to the er due to illness. No troubleshooting was performed as the patient would not allow interrogation of the device with the 8840, patient programmer, or recharger to check the ins status. The only intervention taken by the healthcare provider was reassurance.

Manufacturer Narrative

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 Description

Additional information received from the consumer reported they were in a lot of pain as of (b)(6) 2016. The consumer was unable to troubleshoot as they didn¿t have access to a programmer or recharger. The consumer further reported they had a respiratory problem, which both they and the doctor said was due to the stimulator, which they had been in the hospital twice for. Due to the respiratory problem it made it sound like they were yelling, but they weren¿t yelling. According to the consumer they had the respiratory issue ¿taken of¿ and wanted to make sure the issue was documented.

Event Description

Additional information received from the consumer reported they went to the hospital two days where told they told them ¿they couldn¿t take it out of their back, and if they do they need authorization from their doctor and the manufacturer. ¿ it was confirmed the consumer hadn¿t spoken with their healthcare provider (hcp) about removing the device. The consumer further reported they ¿got a lot of medical problems from their implant and ended up in the hospital with pneumonia where the hcp asked them to have the device turned off until they finished treatment. According to the consumer a manufacturer¿s representative (rep) came to the emergency room in the hospital and didn¿t turn it off and wouldn¿t touch them, but later stated the rep. Came and said they turned stimulation off, but didn¿t so they ended up spending the rest of the time in the hospital with stimulation turned on. Due to the pneumonia the consumer was sweating really bad and soaking wet. The consumer was ¿switching and switched very bad,¿ but the rep. Didn¿t touch the consumer or the device. After the consumer got home from the hospital stimulation was still on for a day or two and either the implant went dead or they were able to turn it off and further stated there was something wrong with their device and it wasn¿t working and that they were very strong and thought it was hurting them too much, but were unable to provide any more clarification on this or if the device was causing them pain. On (b)(6) the consumer met with the rep. At the healthcare provider¿s office who offered to reprogram their device but the consumer refused so they ended up going to a different hospital where they recommended removing the device if the consumer never used it since their back ¿was like a storage room for the device. ¿ according to the consumer the reason they weren¿t using the device was because they needed someone to assist them on waking the battery up as well as how to use it. Currently the consumer wanted someone to help them turn the device back on or they wanted the device taken out.

Manufacturer Narrative

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 Description

Additional information was received from the rep reporting that they spoke to the patient today and they stated that their scs device was not working. The patient was upset and stated that they would seek legal council. The rep offered to meet with the patient at doctor (b)(6) office and the siad that they were trying to arrange an appointment. It was recommended to the patient that they call their health care provider (doctor (b)(6) and then reach out to a rep. No further patient complications have been reported as a result of this event.

• 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: 6113155
• MDR Text Key: 102606840
• Report Number: 3004209178-2016-24348
• Device Sequence Number: 1
• Product Code: LGW
• 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

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/23/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 07/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/18/2016 Patient Sequence Number: 1