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

Model Number 97702

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Anxiety (2328); Complaint, Ill-Defined (2331); Malaise (2359); Numbness (2415); Sleep Dysfunction (2517)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain.The patient reported that she was in a lot of pain and was venting, things were not good.The patient reported that she had been going to her healthcare provider¿s (hcp) every month, trying to do punches with this stuff to loosen up the muscles and whatever and now her leg was numb from her toes to two inches above her knee, she was using a cane.The patient reported that she got a little sick and they gave her a zpack.The patient reported that she was trying with medicine and aleve and vitamins, just lays, 2 nights ago, she couldn¿t sleep because they gave her steroids she took it before she went to bed so then the hcp said to take it in the morning.The patient reported that she was having anxiety attacks because she was in pain and they didn¿t want to give her anything to calm her down because that would open her pain receptors and make her pain medications work better like she is some dopehead on the street.No further complications were reported.The consumer reported that she was feeling a little better and was soaking her leg.Additional information was received from a consumer.It was reported that the patient was getting letters from the manufacturer and just came back from their healthcare provider (hcp)'s office.The patient was calling about a "bad stimulator." the patient called again and stated that they have been trying to get their device out for a year.The patient didn't give any new information.

• 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: 7283673
• MDR Text Key: 100666258
• Report Number: 3004209178-2018-03639
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109513
• UDI-Public: 00643169109513
• 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
• Report Date: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2017
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2018
• Date Device Manufactured: 11/18/2015
• 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