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

Model Number 97714

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Scar Tissue (2060); Burning Sensation (2146); Distress (2329); Complaint, Ill-Defined (2331); Malaise (2359); Post Operative Wound Infection (2446); Fluid Discharge (2686)

Event Date 08/01/2017

Event Type  Injury  

Event Description

Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for lumbar radiculopathy and spinal pain.It was reported the patient had an ins infection.They had drainage and pain.It was reported that following the implant they immediately let them out of the operating room.When the patient was in recovery they stated that they got up and the pad they were sitting on and their shirt was saturated with blood.They stated that they were knocked back out and another couple of stitches were put in them, but they said ¿that didn't do the trick¿ and they just continued to bleed.It was reported that the patient went home really frustrated.They stated that they continued to bleed through friday following their implant and they bled onto their mattress and wrecked their mattress.The patient stated that they would wipe it with an alcohol pad and called the doctor¿s office who were concerned and wanted them to come down to the office.However, the patient stated that they were ¿feeling really "profanity"¿ from the infection and they promised that they would go to the local urgent care.The patient went to the urgent care and their healthcare provider confirmed it was infected.It was reported that it was really hot and blood was coming out of it.The patient indicated that they had previously had a neck fusion (unrelated to device/therapy) so they were taking cephalexin at the time, but that did not do much, so the patient was given bactrim to take in addition.It was reported that it eventually stopped bleeding and then it got really painful (and is really painful) and they developed a huge bulge over s1, l5 which was where the patient had a fusion.Then the patient stated that they weren¿t sure if the bactrim kicked, but they saw their doctor on tuesday and they stated that they told them it looked good.It was reported that there wasn¿t an infection anymore and the bactrim was the right thing to use.The patient just stated that right now it was unfortunately a lot bigger scar than they were led to believe.It was reported the infection was confirmed and oral antibiotics were given to resolve the infection.The event date was the day of implant.No further complications were reported/anticipated.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6801383
• MDR Text Key: 82980688
• Report Number: 3004209178-2017-17645
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/16/2017
• Date Device Manufactured: 06/11/2017
• 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