MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ADVANCED; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37713

Device Problems Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Nerve Damage (1979); Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Complaint, Ill-Defined (2331); Numbness (2415); Electric Shock (2554)

Event Date 11/01/2016

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 regarding a patient who was implanted with a neurostimulator (ins) for post lumbar laminectomy syndrome.It was reported that the patient was not feeling stimulation in their left leg, so in (b)(6) 2016 they met with their healthcare professional (hcp) and a representative (rep) to be reprogrammed.The patient stated the rep kept cranking the stimulation up on the left side and they were not feeling it.They reported that the stimulation felt like it was frying their feet.The patient stated it was like they were being electrocuted and it was hurting their feet really bad.The patient reported that they kept telling the rep to stop but they would not.They noted the rep switched over to the right lead and it worked fine.The rep went back to the left side and kept going higher.The patient stated they told the rep to stop and that they were in pain.The patient report ed that a friend had grabbed them and if they would not have done so, the patient would have hit the floor.They reported that ever since the rep had done this, the patient has had problems with their feet.They noted it would get worse depending on what they were doing.The patient stated they had a numbing sensation from the knee to the ankle just on the left side.They reported that in the beginning, the numbing was off and on, but now it was permanent and had gotten worse.They reported that in the beginning it was manageable, but now the patient was falling a lot.The patient reported that they had arranged to have a doctor take the system out because they were so screwed up permanently.No further complications were reported.Follow up was conducted.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer regarding the patient.It was reported that the patient¿s knee from way down would go numb and there were a lot of thing they could not do.The patient stated that they had injured their right ankle in the last three weeks due to the nerve damage.The patient stated that it was getting worse.The patient stated they wanted to have the device removed.An email was sent to patient relations to have them contact the patient.No further complications were reported.Follow up was conducted.

• Brand Name: RESTORE ADVANCED
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 7562347
• MDR Text Key: 109834369
• Report Number: 3004209178-2018-12406
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2009
• Device Model Number: 37713
• Device Catalogue Number: 37713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2018
• Date Device Manufactured: 08/21/2008
• 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: 43 YR