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

Model Number 97714

Device Problems Failure to Interrogate (1332); Unstable (1667); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Connection Problem (2900); Device Markings/Labelling Problem (2911); Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Date 08/16/2016

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and the other components are: product id: 37751, serial# (b)(4), product type: recharger.Product id: 37761, serial# (b)(4), product type: recharger.

Event Description

The patient reported that the implantable neurostimulator (ins) recharger was dead and not charging.The desktop charger seemed ok.Additional information received from the patient indicated they were getting poor communication on the programmer.They were unable to communicate with the recharger and the last successful charging session was 3 months ago.The connector pin was mislabeled and would only plug in backwards.When the patient aligned the arrows, the pin would not fit.It was noted that the patient stated that the devices did not work.A manufacturer representative (rep) met with the patient to address the overdischarge.The rep showed the patient how to do a physician mode recharge (pmr) but the patient could not remember at the time of the report and couldn't charge the ins.The patient was scheduled for an mri that was not related to the ins or therapy.Additional information received from the rep indicated that they suspected that the ins was put in backwards.The patient did 3-4 pmrs and still couldn't communicate with the ins.The antenna locate (al) feature was done and showed 78-79, with 60 on the left.The patient needed imaging due to pain.A flipped ins was not confirmed, but the rep couldn't initiate a charge on (b)(6) 2016.An x-ray was recommended to confirm if the ins was flipped.The pain was chronic back and leg pain, and no new pain diagnosis.There were bent pins on the desktop charger.The ins was indicated for spinal pain.

Event Description

Additional information was received from the rep and it was reported that the ins was not flipped.The rep reported that it was most likely that the patient was not compliant with the trickle charge and never was able to wake the ins as a result.The rep offered to do it in the office for him, but the patient refused.The ins was explanted.No further outcomes were reported.

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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5937997
• MDR Text Key: 54268155
• Report Number: 3004209178-2016-18560
• 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: 10/26/2016

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: 07/28/2016
• 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: 08/16/2016
• Initial Date FDA Received: 09/08/2016
• Supplement Dates Manufacturer Received: Not provided; 10/19/2016
• Supplement Dates FDA Received: 10/26/2016; 09/25/2017
• Date Device Manufactured: 09/01/2015
• 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): Required Intervention
• Patient Age: 52 YR