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

Model Number 37711

Device Problems Energy Output To Patient Tissue Incorrect (1209); Battery Problem (2885)

Patient Problems Nerve Damage (1979); Undesired Nerve Stimulation (1980); Neuropathy (1983); Pain (1994); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544)

Event Date 02/15/2013

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 for non-malignant pain.It was reported that the patient was calling because they had chronic neuropathy and were wanting to know if their stimulator caused it after having it in their back for 18 years.No further complications reported.Additional information was received from a consumer on (b)(6) 2017.It was reported the patient¿s healthcare professional (hcp) was managing their pain with opioids, but the medication no longer covers the pain in their legs.The patient has severe nerve damage in their lower legs and has neuropathy.The patient stated they had been ¿detreating¿ in their legs, feet, thighs and lower back where the leads are placed.The leads were in the patient¿s back for 14 years and the hcp said the neuropathy could be possibly related.The patient is in a recliner or wheel chair and stated it felt like hot coals and they can¿t walk.The patient has diabetic shoes to relieve the pain on the bottom of their feet, but it doesn¿t help.The patient stated both lower legs were progressing up into the knees, thighs, and lower back.The symptoms were gradual and began 9-10 months ago.No further complications were reported.Additional information was received from the patient on 2017-oct-23.It was reported that they first started experiencing the chronic neuropathy in (b)(6) 2017.On (b)(6) 2017, the patient¿s healthcare provider (hcp) performed a nerve test which revealed the issue.The patient stated that their stimulator battery died in (b)(6) 2018 and still felt like it was on after 14 years of use.The patient stated that the device was removed in (b)(6) 2015.It was noted that these dates didn¿t correlate with our device records.The patient stated that they still felt light stimulation in areas covered by the device and it continued to get worse.The patient stated that the issue hadn¿t been resolved and that they were managing it with medicine.No further complications were reported or 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 on 2017-nov-13.It was reported that the issue of the battery dying and the unexpected stimulation started on (b)(6)2013.No further complications were reported or anticipated.

• Brand Name: RESTORE
• 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: 6991292
• MDR Text Key: 90702799
• Report Number: 3004209178-2017-22869
• 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: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2008
• Device Model Number: 37711
• Device Catalogue Number: 37711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2017
• Date Device Manufactured: 02/13/2007
• 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: 67 YR
• Patient Weight: 82