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

Model Number 97702

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Nerve Damage (1979); Pain (1994); Swelling (2091); Burning Sensation (2146); Immunodeficiency (2156); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544)

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

A patient reported she wears a back brace.The patient reported she was in the hospital for 7 days and she thought she would have surgery.It was difficult to keep the patient on track to find out when or clarify the report.The patient said they told her she could not have injections now because a nerve is torn and it would have leaked out of her spine.The patient reported they had been on pain medication.The indication for implant was non-malignant pain.

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 was received from a patient on 2018-mar-23.The patient saw a specialist on the day of the report and was feeling upset because of how it went.At the appointment the patient¿s son asked why prior healthcare professionals (hcp) say the implant should have never been done in the first place, there is nothing wrong with their spine.The hcp told them that a different hcp would not do the surgery to remove it because of the patient being bipolar and the psychiatrist report which says that the patient talks too much and is weak.They have been gathering their health records trying to help.It was noted thatthe patient¿s body was becoming immune and they are cutting down on their medications.It was reviewed that when the patient calls patient services that the call reports are not health records and are only for internal use.The patient¿s hcp has their protectedhealth records so they can get those from their hcp.The patient stated that they have been in pain for about a week.Their knee is acting up again.Their baker sack which previously exploded in the back of their knee is coming back.The ¿pertiel sack¿ that pops out of the bone, it is hard to get out of the house because it has 6 steps.They are going to have a nerve test on their right leg.Additional information was received from the patient on 2018 (b)(6).The patient has two appointments coming up to check the nerve in their leg on the (b)(6).They had two previous ultrasounds to check for a blood clot in their knee and private area.They found the baker sack behind their knee but the hcp told them that there was nothing wrong with their leg.The ins site swelling comes and goes but it is going down.Their knee and ankle are swollen and the area between their groin are is burning.The patient clarified that it is the line of their pants crease; it feels like a stream of hot water running down their leg and their calf feels like a pumped-up balloon and it burning standing which causes them to need to get off of their leg.This began a couple of week ago in (b)(6).The patient stated that they told them that there was not a lunar tear.The patient said if that is the case then why did the hcp put the stimulator in there; maybe the hcp was reading someone else¿s myelogram report or something the patient said.The patient stated that maybe it is just the leg.All they know is when they fell, 3 toes were like glass in them.They were limping and something happened.They wish their hcp never.This occurred prior to getting the spinal cord stimulator (scs) and was the reason they got the ins.No further complications were reported/are anticipated.

Manufacturer Narrative

Updated to correctly reflect that there was an adverse event and no product problem.If information is provided in the future, a supplemental report will be issued.

Event Description

Updated to correctly reflect that there was an adverse event and no product problem.

• 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: 6361866
• MDR Text Key: 68431707
• Report Number: 3004209178-2017-04674
• 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,Followup,Followup,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• 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: 04/09/2018
• 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
• Patient Outcome(s): Hospitalization