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

Model Number 97714

Device Problems Migration or Expulsion of Device (1395); Pocket Stimulation (1463); Charging Problem (2892)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Type  malfunction  

Manufacturer Narrative

Concomitant product(s): product id: 97754, serial# (b)(4), product type: recharger.Product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.(b)(4).

Event Description

It was reported that stimulation was giving the patient a pinching sensation on one of her sides and she got sore after a while.It had been like that since implant.However it was getting more intense, but the patient could'nt say when it got more intense.It would hurt to the point where she had to turn therapy off, but she could not keep it off for long because she needed therapy.It was later reported that the patient still had concerns regarding her device or therapy and she was working with her doctor or manufacturing representative (rep).The patient requested a rep to be her appointment at the doctor's office on (b)(6).It was later reported that no actions were taken at the appointment as the patient had injections done and the reps could not do any testing at that time.The patient rescheduled her appointment for (b)(6) 2015.The cause of the issue was not determined at that time.At the appointment, the patient was getting good coverage with her stimulator but at times she was feeling pinching sensation at the battery site.Charging was also difficult, which began shortly after implant, but no symptoms were associated with the charging difficulty.The rep ran an impedance test and all were ok.The doctor ordered an x-ray and the battery looked good but the right lead moved one contact down.When the patient sat the battery felt like it moved and it was poking her at the battery site.The doctors were going to discuss a possible pocket revision or battery replacement.The issues the patient was having with the stimulator might have been due to the battery movement.It was noted that standing or lying down flat seemed to help the patient with charging.

Event Description

Additional information received from the manufacturer representative (rep) reported that the patient had experienced an uncomfortable pinching sensation at the pocket site.Several reprogramming sessions had taken place to minimize discomfort; including higher and lower frequencies.When another reprogramming was attempted, the patient reported the discomfort immediately returned and went away when the implantable neurostimulator (ins) was shut off.Impedances performed were within normal limits and x-rays were taken of the lead site and lead/ins connection site.In addition, the ins was assessed at a tilt and the top part stuck out; adding to the patient's discomfort.They had met with the doctor and physician's assistant to discuss a new pocket and a possible ins replacement.If additional information is received, a follow-up report will be sent.

• 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: 4945866
• MDR Text Key: 23110575
• Report Number: 3004209178-2015-14170
• 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: company representative,consum
• Reporter Occupation: Other
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/13/2015
• Date Device Manufactured: 09/23/2013
• 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