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

Model Number 97714

Device Problems Failure to Interrogate (1332); Failure to Power Up (1476); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Connection Problem (2900); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 02/01/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 97740, serial# (b)(4), product type: programmer, patient.Product id 97740, serial# (b)(4), product type: programmer, patient.Product id 97754, serial# (b)(4), product type: recharger.Product id 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id 97740, serial# (b)(4), product type: programmer, patient.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

It was reported that the patient programmer (pp) was 100% broken.The patient attempted to reach the manufacturer¿s representative (rep) who said they would call the patient back to troubleshoot but they hadn¿t heard anything yet.The patient was back to having an average of eight on a pain scale.The patient reported it was awful as they had about 80% relief with the device prior and were now no longer able to work.The manufacturer¿s representative (rep) contacted the patient who stated the patient programmer (pp) was the device they were having an issue with and it wasn¿t turning on.They had not been able to use their implantable neurostimulator (ins) because they didn¿t have a functioning pp.The first time the rep.Heard about the patient having pain due to a non-functioning device was on (b)(6).The patient didn¿t have a pp so a request was made to get a replacement sent overnight.The patient was working on trying to recharge the ins and was going to contact the rep.To let them know if they were able to charge the ins.Additional information received from the manufacturer's representative (rep) reported the patient programmer would not power up.Since neither the patient nor the rep had the programmer with them at the time of the call, it was reviewed that they should call back for further troubleshooting before transferring to repair.The rep was going to give the patient one of his patient programmers in the meantime.Later, it was noted the patient did receive a replacement patient programmer and they were able to recharge their implantable neurostimulator (ins) and get effective stimulation.Relevant medical history includes non-malignant pain.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 37761, serial# (b)(4), product type: recharger.Product id: 97754, serial# (b)(4), product type: recharger.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.The desktop charger (dtc) [serial# (b)(4)], the implantable neurostimulator recharger (insr) [serial# (b)(4)], the patient programmer [serial# (b)(4)], and the implantable neurostimulator (ins).

Event Description

Additional information received from the consumer via the manufacturer representative reported that the patient had issues with the implantable neurostimulator recharger (insr) since (b)(6) 2015, there was a loose connector pin on the desktop charger (dtc), and the dtc was unable to charge the insr.It was noted that prior to this, the patient used the recharger every day.For approximately 2 weeks, the green light was out but the patient was still able to recharge and use it.Then, the patient worked with the manufacturer representative to troubleshoot it, but by (b)(6) 2015 the insr was completely non-functional.The insr was unable to power on and had a blank screen, even when plugged into the wall.Resetting the insr did not resolve the issue.It was noted that the patient had not charged since (b)(6) 2015.There was no alleged out of box failure.Additional information received from the healthcare professional on 31-may-2016 reported that the spinal cord stimulator (scs) was broken for 18 months.Potential overdischarge was reviewed as the scs was not used in 18 months.It was noted that troubleshooting resolved the reported issue.Additional information received from the consumer via the manufacturer representative reported that the patient programmer would not power up and the batteries had been replaced; the issue started more than a year prior to (b)(6) 2016.There was no alleged out of box failure.It was also reported that the patient was unable to charge the implantable neurostimulator (ins) and the insr was not connecting to the ins; the manufacturer representative became aware of these issues in 2015.The dtc was replaced at some point, but did not resolve the issue; the manufacturer representative thought the issue was either with the insr or the recharge antenna.Additional information received from the consumer via the manufacturer representative reported that error code 376: antenna test-temp failure was seen on the implantable neurostimulator recharger (insr) (b)(6) 2016 and a warning power on reset (por) code was seen on the insr/patient programmer on (b)(6) 2016.It was noted that the reported por was related to an overdischarge event; the patient planned to meet with the manufacturer representative to clear the por.It was reported that the ins had been depleted for about a year and a half and the ins had not be en working for a year and a half.The patient spoke with the manufacturer representative on the phone (b)(6) 2016 about a suspected overdischarge; the manufacturer representative talked the patient through how to get the ins going again so she could recharge.

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 MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5564570
• MDR Text Key: 42267837
• Report Number: 3004209178-2016-07130
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2016

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: 10/28/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/23/2015
• Initial Date FDA Received: 04/08/2016
• Supplement Dates Manufacturer Received: Not provided; 05/27/2016
• Supplement Dates FDA Received: 06/24/2016; 09/21/2017
• Date Device Manufactured: 12/06/2013
• 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 Age: 54 YR