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

Model Number 97714

Device Problems Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problems Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Discomfort (2330); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

The patient¿s health care provider (hcp) confirmed that the patient had the battery site changed on (b)(6) 2014.The patient was happy with placement at discharge.The patient¿s back pain was improved by 80%.The hcp has not heard or seen from the patient since (b)(6).It was unknown how the patient was doing.

Event Description

The patient had to have a revision on (b)(6) 2014 to move the implantable neurostimulator (ins) down because the ins was exerting pressure on her spine.The ins was revised as low as it could go.An issue was determined once the swelling went down from initial implant on (b)(6) 2014.It was (b)(6) 2014 when both the doctor and company representative were at the patient¿s appointment and found out about her issues.The patient thought the revision surgery was only going to last one hour but it was several hours (4-5).It was noted that initial implant surgery was five hours.The patient also had issues with anesthesia, so she had to stay in the recovery room longer and had to stay overnight post-surgery.The patient was upset that no one asked how the device was working after the revision surgery.The patient did not believe they really know about the device or how it operates because, they did not know if the ins should be turned off or left on for surgery.They thought the ins needed to be replaced but the patient stated it was working great, and only needed to be placed lower on her spine area.Percocet and muscle relaxers needed to be administered to the patient, so she could lay down because of the pain.The patient believed the ins was revised and re-implanted upside down.When the patient makes adjustments she feels like the right and left sides of her body were opposites from what it was with the first implant settings.When the patient got the staples out at her post-op doctor appointment, she felt ¿like a million bucks.¿as the swelling continued to go down, that was when the patient noticed the ins was not placed properly in her body; her doctor agreed with her so a revision was done.With the first implant surgery the patient would get six bars when recharging the ins but now since the revision, she was lucky to get four bars, usually two bars and then she loses the signal.The patient was able to charge her ins 70% of the time.Patient noticed the issue more this last sunday.The temperature too high symbol appeared when recharging and she has to wait, then tries again to recharge the ins.It has taken six hours to recharge the ins and the patient¿s skin was burning.The ins now seems to be implanted further in her body and it sits at a slant.The patient had to cancel her appointment with her doctor for (b)(6) 2014 and was rescheduled for (b)(6) 2014.Additional information has been requested to find out if any additional intervention or troubleshooting was required and to obtain the outcome of this event.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

Product id 97754, serial# (b)(4); product type recharger product id 39565-65, serial# (b)(4), implanted: 2014 (b)(6); product type lead product id 97740, serial# (b)(4); product type programmer, patient product id 97754, serial# (b)(4); product type recharger.(b)(4).

Event Description

The patient clarified almost two months later that when the ins was moved, it was to her hip.The battery was placed at a slant and was turned at an angle.The patient has a very hard time charging and was told to try sticky patches; she wondered how to obtain the sticky patches to use on her external charger.The patient was trying her best to not have another surgery.

Manufacturer Narrative

The previously reported evaluation code-results code has been updated: no longer applies to the event.See also manufacturer¿s report # 3004209178-2016-13516 for the patient¿s other device issue.

Event Description

Additional information received from the patient confirmed that when the ins was implanted it was put in the wrong place (next to spine).It was in a location where they had prior pain with the result they had pain all the time and could not lay down.A revision occurred where the ins was taken out and moved lower to the upper right butt cheek (in the crack).After the ins was moved it was at a slant/tilt.The patient could only feel half of the ins because it was "buried".As a result they had a difficult time charging, could not get a full charge, and got 6 coupling bars because of the slant/tilt of the device and that "cannot make out the lower part of it".The indications for use for the implanted device were noted as spinal pain and failed back surgery.There were no further details, troubleshooting, interventions, or an outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.

• 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 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: 4277372
• MDR Text Key: 5143128
• Report Number: 3004209178-2014-22189
• 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,Health Professional,consumer,health profess
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/05/2016

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: 07/28/2015
• 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: 01/20/2015
• Initial Date FDA Received: 11/25/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/25/2014; 12/18/2014; 01/26/2015; 07/05/2016
• Date Device Manufactured: 09/06/2014
• 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: 00044 YR