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

Model Number 97714

Device Problems Energy Output Problem (1431); Improper Device Output (2953)

Patient Problems Nerve Damage (1979); Neuropathy (1983); Pain (1994); Therapeutic Effects, Unexpected (2099); Tissue Damage (2104); Anxiety (2328); Complaint, Ill-Defined (2331); Numbness (2415)

Event Date 02/27/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977a275, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.Product id: 977a275, serial/lot #: (b)(4), ubd: 05-nov-2018, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for spinal pain.It was reported that the patient had the ins implanted in their lower back with the leads going into their spine and shoulder blade.The patient stated that "my back right shoulder blade has a weird, almost like the nerve endings were dead, it was hurting where the lead was put in i guess, it hurt and hurts still 3 years later bad, its kind of numb, its kind of hard to explain, its like going to the dentist, where on the surface its numb, and below its painful".The patient said the reason for calling was because they wanted to know if this was permanent damage (numbness, tissue damage).The patient stated they met with a manufacturer representative (rep) who told them that this problem was "normal".The patient said the rep was blunt and honest which they appreciated, and told the patient that they have to force a tube up to the shoulder blade up through the tissue and put the leads through it; the patient added that they had spoken to a few reps about this.Patient services (ps) reviewed that this was a medical question and that the patient will need to address their concerns with the healthcare professional (hcp).The patient noted that they will see their hcp in (b)(6).Ps reviewed if a rep is requested, then the hcp can coordinate getting a rep out to that appointment.The patient reported that it still hurt, and where the leads were put in they have as much pain there as they do with their nerve damage in their neck and right arm (the patient indicated the damage in neck and right arm were why they got the ins implanted).The patient stated that they spoke to the hcp and was told that "no that's not where we put the wires".The patient said they know for a fact it is, because when they spoke to the hcp after the surgery they told him exactly where it went.The patient said they know their body and knows something is not right with the shoulder blade.The patient stated they were having constant pain back there in the shoulder blade where the leads were put in.The patient confirmed that this problem had been since the surgery ("since day one").The patient also reported that there was another issue too because they didn't turn the ins on anymore because when they turned the ins on, they couldn't get the ins to turn off, even with the programmer or recharger.The patient noted getting frantic because it was "annoying thinking they had something in them that they couldn't control".The patient stated it took them more than 2 hours to get the ins to turn off.The patient noted that they kept their ins charged and checks the ins every 1-1.5 months.The patient said that it happened more than once when they experienced not being able to turn the ins off themselves.The patient stated that "probably early 2016" is when they first experienced this issue.The patient said they met with a rep in the hcp office to troubleshoot and while they were in the office everything worked; the patient said they did not know when they met with the rep regarding this issue.The patient was directed to their hcp.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a health care provider regarding the patient.It was reported that the lead was placed in the right scapular and that it has been hurting since implant, so it is not helping the patient¿s pain.The patient needs an mri.There were no further complications reported.

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.

Manufacturer Narrative

Conclusion code omitted from previous report.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 the patient.It was reported that there were no circumstances or activity that led to the inability to turn the ins off, it just wouldn't work (cut off); the patient said they just kept trying to shut the ins off for over 2 hours.The patient stated that the inability to turn the ins off and the pain in their shoulder blade had not been resolved.The patient said they were afraid to cut it on plus the pain due to inserting the wire lead in their shoulder (they were told this was permanent damage to their tissue).The patient stated they regret having the implant and they were not told all of the effects.No further complications were reported.

• 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
• MDR Report Key: 7639219
• MDR Text Key: 112745235
• Report Number: 3004209178-2018-14392
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 07/11/2018; 07/11/2018; 09/10/2018; 08/08/2018; 08/08/2018
• Supplement Dates FDA Received: 07/11/2018; 07/12/2018; 09/12/2018; 10/02/2018; 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR