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

Model Number 97712

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Loss of consciousness (2418)

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 977a290, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.Product id: 977a290, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.(b)(4).Note: see regulatory report # 6000153-2016-00181 regarding the lead issues.

Event Description

A patient who had an implanted neurostimulator (ins) for other and non-malignant pain reported on (b)(6) 2016 that they thought the permanent implant would be just like the first trial, with the leads like "railroad tracks." however, when they woke up from surgery, they only had two electrodes on the back of their skull where the occipital nerve is.It was noted that there was a "blue plastic connector square" where the cables connect in their neck, and a second connector in their mid-back area.It was also reported that the electrode on one side of their head was moving quite a bit, and the ins was also moving quite a bit in their hip.It was stated that the patient would black out if they turned their head or lifted their arms.This had been occurring once every other week since implant.The patient stated that they had pre-existing conditions including a blood clotting disorder, strokes, several genetic disorders, they "ultra-metabolizes" medications, goes into withdrawal, and had tried marijuana for nausea.Follow up efforts have been initiated to determine what steps had been taken to resolve the ins movement, lead movement, pain, and blacking out issues.A supplemental report will be submitted if additional information is received.

Manufacturer Narrative

(b)(4).

Event Description

The patient also reported having horrible head pain from "inter-cranial minus pressure" and would get horrible pressure headaches when they would lift their head.

Event Description

Additional information received reported every once in a while, the patient blacked out if she turned her head or lifted her arms.This issue began after the stimulator was implanted and was due to the stimulator.The patient noted that this had been happening once every other week since implant.A supplemental report will be submitted if additional information is received.

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 patient.It was reported that the spinal stimulator was put in incorrectly.The patient had it removed by another doctor.

• 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: 5383276
• MDR Text Key: 36529892
• Report Number: 3004209178-2016-00847
• Device Sequence Number: 1
• Product Code: LGW
• 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,Followup,Followup,Followup
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2015
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2016
• Date Device Manufactured: 08/25/2014
• 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: 00051 YR