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

Model Number 97714

Device Problem Positioning Problem (3009)

Patient Problems Pain (1994); Pocket Erosion (2013); Test Result (2695)

Event Date 02/25/2016

Event Type  Injury  

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

The manufacturer representative reported that they were scheduled to see a patient implanted with an implantable neurostimulator (ins) but wonder if the patients body could be rejecting the implant.It was reported that the patient had an elevated white blood cell count for more than few months and the physician is indicating there are signs of infection but they dont know where it could be located.It was reported that the patient indicated that they sometimes feel that the ins is protruding and they could see the whole outline of the implant.It was reported that the protrusion was noticed a couple of months prior to the report.It was reported that the ins pocket site looks fine and there is no redness or warmth but the pocket site is sensitive to touch.There is pain at the pocket site and mid-back.It was reported that patient has other medical issues (not related to stimulator) including knee replacement, sleep apnea, liver enzymes, anxiety/panic disorder, afib.The patient had prior back surgeries that led to pain and getting the i ns.It is unknown how those conditions or the device may be contributing to elevated white blood cell count and possible infection.It was reported that the physician is working with the patient for the white blood cell count and possible infection issues.The patient indication for use is non-malignant pain.

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 rep reporting that they met with the patient and on this particular day there were no visible signs of the pocket protruding from the pocket or feeling that the site was tender to the touch.The stimulator placement was stated to be normal.

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: 6102558
• MDR Text Key: 59885795
• Report Number: 3004209178-2016-23994
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2016
• Date Device Manufactured: 01/18/2016
• 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: 34 YR