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

Model Number 97702

Device Problems Unintended Collision (1429); Overheating of Device (1437); Pocket Stimulation (1463); Device Contamination with Chemical or Other Material (2944)

Patient Problems Undesired Nerve Stimulation (1980); Burning Sensation (2146)

Event Date 04/01/2017

Event Type  Injury  

Event Description

Information was received from a health care professional (hcp) via a manufacturer representative regarding a patient who was implanted with a neurostimulator for spinal pain.It was reported that the patient had a fall at the end of (b)(6).There was no reported electromagnetic interference (emi) and the patient did not experience symptoms when the implantable neurostimulator (ins) was off.Impedance measurements were taken and all came back normal.It was reported that there was a burning sensation and uncomfortable stimulation at the ins pocket site.This was a sudden change that occurred after the fall.The manufacturer representative met with the patient to reprogram and currently the patient had to turn off stimulation because they felt the burning at 0.1v so this issue was reported to be intermittent.No further complications were reported.

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 from the manufacturer representative on 2017-06-23 reporting that a surgery was scheduled for (b)(6) 2017 to clear a possible fluid short.No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the patient indicated that during the surgery, the electrodes were disconnected from the ins.It was noted upon inspection that there was some moisture within the ins itself.It is possible that the head of the ins was loose again, allowing possible moisture.No further complications were reported.

• 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6623308
• MDR Text Key: 77024276
• Report Number: 3004209178-2017-11916
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169109513
• UDI-Public: 00643169109513
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2018
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2017
• Date Device Manufactured: 08/04/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 105