MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97713

Device Problems Migration or Expulsion of Device (1395); Unintended Collision (1429); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Bone Fracture(s) (1870); Nerve Damage (1979); Pain (1994); Discomfort (2330); Complaint, Ill-Defined (2331); Electric Shock (2554); Disc Impingement (2655)

Event Date 08/23/2016

Event Type  Injury  

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

It was reported that the patient's left leg gave out two weeks prior to the report when she was reaching for something and then fell down.The patient experienced pain, pinching, and shocking in the left leg and ankle.This was considered to be a sudden change in symptoms.Due to the symptoms, the patient went to the emergency room (er) and was told the pain could be sciatic pain.The patient was concerned that a lead could have moved and stated that her knee was getting worse.An appointment was scheduled for (b)(6) 2016.Follow-up has been attempted, but no further information was received at this time.If additional information is received, the event will be updated.The indication for use for the implanted device was noted as non-malignant pain and chronic low back pain.

Manufacturer Narrative

Other applicable components are: product id 3998, lot# n26491, implanted: (b)(6) 2003, product type: lead.

Event Description

Additional information received reported that the patient was seen on (b)(6) 2016 by their physician and was told they had nerve damage in their back.They were also told that the issues were due to the nerve stimulator leads in the back.The patient was sent to the er for an mri to determine if they needed new nerve stimulator leads.The workup was still continuing and the etiology/outcome was not known.

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

Follow up information received from the patient reported that they were not sure yet if any diagnostics or troubleshooting was performed for the issue and noted that they had missed their first 2 appointments (my fault) for shots at the doctors office.The patient saw an er doctor and was diagnosed with sciatic nerve damage.The patient also noted that they wrecked in 1998, almost didnt walk again, and had a fractured spine and t5-t6-t7 discs were bad (went down a bad road with chronic pain).They stated that they had the leads in their back of a long time.The patient reported that both their stimulator and pump had changed their life and could better handle the chronic pain every day.The patient hoped they did not have sciatic nerve damage and that they did not have to replace the leads.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5989817
• MDR Text Key: 55999500
• Report Number: 3004209178-2016-20086
• 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,Followup,Followup
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2014
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2016
• Date Device Manufactured: 06/06/2013
• 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): Other
• Patient Age: 50 YR