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

Model Number 97714

Device Problems Device Operates Differently Than Expected (2913); Impedance Problem (2950); Material Deformation (2976)

Patient Problems Seroma (2069); Twiddlers Syndrome (2114)

Event Type  Injury  

Event Description

It was reported that the patient had a replacement done (b)(6) 2014.The reason for replacement was not given.Right after it was replaced, it was reported that it wasn¿t hooking up right to her leads.The patient had a revision on (b)(6) 2014 where fluid was found around the stimulator and was drained.It was stated that the stimulator was pulled closer to the surface of her abdomen.It was further reported that the extension was twisted by hand in the patient¿s abdomen, as she was a large patient and played with it.The extension was replaced during the (b)(6) 2014 revision and everything was fine.The patient left happy.It was further reported that the cause of the lead/extension not hooking up correctly was not determined.It was further reported that when the extension was replaced, the fluid that was drained was tested for infection, which was stated to be fine.It was further reported that impedances were off "sometime in (b)(6)." numerous attempts have been made for follow up information.If received, a follow up report will be sent.

Manufacturer Narrative

Product id: 3998, lot# v013615, product type: lead.Product id: 97754, serial# (b)(4), product type: recharger.Product id: 97740, serial# (b)(4), product type: programmer.Patient product id: 3708260, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the leads were placed into the implantable neurostimulator (ins) in the correct manner and the impedance check yielded acceptable readings.The ins pocket was closed after the impedance test.It was further reported that on (b)(6) 2014 the patient's impedances were noted to be high.The doctor decided to replace the device at that time and set up a lead revision for a later date.On (b)(6) 2014 the patient was seen by a manufacturer representative and the impedances were still high.On (b)(6) 2014 the patient had a lead revision.After the revision the patient reported good coverage from their stimulator.The representative thought that the patient was doing great and had good coverage.Additional information has been requested, but was not available as of the date of this report.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; 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: 3863730
• MDR Text Key: 4565314
• Report Number: 3004209178-2014-11268
• Device Sequence Number: 1
• Product Code: GZB
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/12/2014
• Date Device Manufactured: 01/20/2014
• 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: 00038 YR