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

Model Number 97714

Device Problems High impedance (1291); Impedance Problem (2950)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 02/28/2015

Event Type  Injury  

Event Description

It was reported that the lead had broken.The healthcare provider (hcp) told the patient that the week prior and was recommending a revision.The patient was still having concerns with their device or therapy but was working with their hcp or manufacturer representative and they were still waiting for an appointment date.If additional information is received, a follow-up report will be sent.

Event Description

No stimulation sensation was reported.The patient fell in the snow a couple days ago, then he noticed two nights ago the implant appeared to shut off at night; so he turned it on but hasn¿t felt stimulation since that two nights ago.The patient was at the following settings: program one 3.60, program two 7.60, and program three 6.70.The patient increased program one first to 8.00, then entire group but still did not feel stimulation.An information request was made regarding the patient programmer (pp).Two days later it was reported the patient had a fall on sunday and then noticed on monday he lacked stimulation sensation.Impedances were checked today and found multiple instances of electrodes paired over 40,000 ohms; tested at 3v reference 0 all greater than 40 ,000 ohms, reference 1 some are at 1,100 with others out of regulation (oor), reference 8 all over 40,000 ohms.Group impedances, a1-3 are all over 40,000 ohms.Nine days later the patient still had concerns with his device or therapy but was working with his doctor or company representative.Ten days later the company representative confirmed the physician ordered an x-ray and there were no visible kinks or fractures noted.They were able to reprogram the lead and provide equivalent relief.There are three contacts working.They were able to check the connection of the leads at the battery, and that also appeared okay.The patient was encouraged to talk with his insurance company to see if they covered a lead revision or replacement.The patient is receiving adequate stimulation at this time.Additional information has been requested.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id 97754, serial# (b)(4), product type: recharger; product id 97740, serial# (b)(4), product type: programmer, patient; product id 977a160, serial# (b)(4), implanted: (b)(6) 2013, product type: lead; product id 977a160, serial# (b)(4), implanted: (b)(6) 2013, product type: lead; product id 977a160, serial# (b)(4), implanted: (b)(6) 2013, product type: lead; product id 977a160, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported that the patient fell and since then stimulation wasn't working.As a result the patient experienced less than 50% therapy relief and decreased stimulation in the back and leg with intermittent jolting.High impedances of greater than 10,000 on all electrodes except #2 were reported.The patient was feeling intermittent stimulation and it wasn't helping the pain.It was noted there was a break/fracture of the lead/extension, however, an x-ray verified the leads were still in place and there was no obvious fracture/break.The physician was going to schedule the patient for dual lead replacement but the date was to be determined.At the time of the report the issue was not resolved.At the time of the report the patient was alive with no injury.No outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4632665
• MDR Text Key: 5737260
• Report Number: 3004209178-2015-05399
• Device Sequence Number: 1
• Product Code: GZB
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2015
• Date Device Manufactured: 09/19/2013
• 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): Required Intervention
• Patient Age: 00052 YR