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

Model Number 97712

Device Problems Failure to Deliver Energy (1211); Battery Problem (2885); Charging Problem (2892); Device Operates Differently Than Expected (2913)

Patient Problems Emotional Changes (1831); Fall (1848); Muscle Weakness (1967); Pain (1994); Therapeutic Effects, Unexpected (2099); Tingling (2171); Complaint, Ill-Defined (2331); Injury (2348); Peroneal Nerve Palsy (2362); Numbness (2415); Ambulation Difficulties (2544)

Event Date 12/31/2016

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 97754, serial# (b)(4), product type: recharger.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 consumer reported that they got a new device implanted on the wednesday before the report and it stopped working on the saturday prior to the report.They were not able to charge the implantable neurostimulator (ins) and were seeing an icon on their recharger telling them to charge the recharger battery.The patient had experienced a loss of stimulation.The patient was instructed not to charge the ins until their follow-up appointment on (b)(6) 2017 and was told the battery would last two weeks but it didn¿t last more than a couple of days.The patient noted that they had emotional problems, were hurting, and in pain and didn¿t want to troubleshoot over the phone.Due to the device not working the patient fell and hurt their ankle on (b)(6) 2017.The patient had drop foot because of the nerves in their lower back and had to use a brace.They also suffered from chronic pain and would lose their balance.It was also noted that the patient didn¿t have full control from their waist to their arms and didn¿t have the strength to pick things up if they dropped them.They would have to lay their arms across their legs to reach and try to pick things up.

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

Additional information was received from a healthcare provider (hcp) regarding an implantable neurostimulator (ins) for the treatment of spinal pain and lumbar radiculopathy.It was reported patient has some past medical issues that are unrelated to the device and therapy.The patient stated that they have had back and leg pain since 2003.The patient states that most of the pain begins in their low back, will radiate to their buttocks bilaterally down to their legs with the pain in the right side greater than the left along the posterolateral aspect of the right leg along the l5-s1 distribution.Currently the patient describes their pain as sharp, spasm, tingling, numbness, stabbing, and tiring pain; worsens with activity such as exercise, walking, standing, lifting, bending, lying, sitting, rest, heat, and cold.The patient stated that the pain improves with nothing but pain and neuromodulation.Currently the patient describes their pain as constant, worse in the morning mid-day and evenings.The patient rates their pain at 9/10 right now, the worst 10/10 and average daily pain is 9/10.The patient was referred as they had gotten a scs trial and they did very well.The patient stated that they had anywhere from 60-75% relief with the trial and wanted to continue with the implantation of the device.When asked about the pain association they complained about numbness and tingling in their right leg.The patient has what they describe as drop foot on the right leg and difficulty walking but this is associated with the pain.The patient believes this happened after the surgery, which occurred in 2006, and was before the patient was implanted.

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 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6279471
• MDR Text Key: 65835232
• Report Number: 3004209178-2017-01788
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109506
• UDI-Public: 00643169109506
• 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
• Report Date: 02/15/2017

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: 10/14/2017
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/03/2017
• Initial Date FDA Received: 01/26/2017
• Supplement Dates Manufacturer Received: Not provided; 02/09/2017
• Supplement Dates FDA Received: 02/15/2017; 09/29/2017
• Date Device Manufactured: 11/23/2016
• 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: 63 YR