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

Model Number 97714

Device Problems Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Bruise/Contusion (1754); Fever (1858); Skin Discoloration (2074); Vomiting (2144); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Date 03/16/2017

Event Type  malfunction  

Event Description

Information was received from a manufacturer representative regarding a patient with an implantable neurostimulator (ins) for the treatment of non-malignant pain and other chronic/intract pain (trunks/limbs).It was reported that the patient was unable to charge.The patient reported that they were not longer receiving good coverage in the target area as of (b)(6) 2017.The patient experienced a shocking sensation in the scrotum and rectum and the arm/neck and face area instead of the target area of the lower back and right lower extremity.It was noted that this happened when the stimulation was turned off.The stimulation was returned to the target area and the stimulation in the undesired locations ceased when the ins was reprogrammed on (b)(6) 2017.The patient reported that it felt like the ins itself had shifted 1 ¿ 2 inches in the pocket with relation to the spine.It was noted that the patient also had a fever starting on (b)(6) 2017.It was reported that the patient went to the er on (b)(6) 2017, which was 3 days after the onset of yellowish skin discoloration all over the body and in the eyes.No further complications are anticipated.

Manufacturer Narrative

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

Additional information was received on 2017-03-24 from the consumer reporting that the ins looked like it was bruised, the patient had become feverish, was vomiting, and had both skin and eye discoloration since (b)(6) 2017.The patient therefore went to the emergency room (er) and was checked for viruses.The patient had been told that they did not have anything and was given pain medication with the recommendation to see their managing health care professional (hcp) the next day.The hcp met with the patient on monday and looked at the incision site.The hcp told the patient that they had never seen anything like that before.The patient saw a manufacturer representative the next day.Additional information was received on 2017-03-29 from the health care professional (hcp) via a manufacturer representative reporting that it was unknown if the issues had resolved.No further complications 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: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6422016
• MDR Text Key: 70524046
• Report Number: 3004209178-2017-06072
• Device Sequence Number: 1
• Product Code: GZB
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2017
• Date Device Manufactured: 11/25/2016
• 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: 32 YR