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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); High impedance (1291); Communication or Transmission Problem (2896)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Event Description

The patient has been having charging problems since implant.The ins was completely dead.The patient has been trying to charge and she has had troubles, she was not getting bars when trying to charge.The stimulation stopped about 3 days ago.The patient last charged about a week and 2 days ago.The patient normally charges every week.The patient is not near any emi when charging.It was mentioned that the patient has 2 other implants.The implant was showing off on the recharger.The charger was plugged in and the patient tried to use it and it showed full efficiency bars.The bars dropped by 2 bars.For 2 days the recharger bars started out full and then they reduce or go completely blank.The patient has been charging for 2 days and the ins was not taking a charge.The ins battery level stays empty.The patient was confusing coupling bars with ins charge level.Recharging information was reviewed with the patient.It was additionally reported that there was a coupling problem.The ins may be flipped.The patient has had poor coupling since implant, getting between 0-2 boxes.The patient was told to try to ¿move¿ it around, she has taken this to mean try different physical location as she alluded to the fact that she got zero coupling boxes at home but could get 2 boxes in other places.The patient has tried to use the dial, move the recharger and has charged for hours and hours on end but still struggled with it.The patient has talked to her managing physician about it.The implant was currently completely dead.The patient needed to call her doctor again and figure the issue out because charging with 2 boxes was not sustainable.The patient¿s health care provider (hcp) reported the device needed to be evaluated because the patient was in an accident.After being in a car accident the patient has had abnormal impedance measurements of greater than 10,000 ohms with the following electrode combinations: 0 <(>&<)>1, 1<(>&<)>2, 1<(>&<)>3 and 1<(>&<)>4.The following was noted ¿wasn¿t working¿.A lead/extension issue was ruled out.On (b)(6) 2014 the patient had a mri/x-ray/ct scan and it showed everything in place.The device was reprogrammed on (b)(6) 2014.Hospitalization was not required.Patient outcome was noted as no injury.The patient was doing well and the ins was functioning.

Manufacturer Narrative

Concomitant products: 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) 2014, product type lead; product id 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type lead.(b)(4).

• 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: 3808643
• MDR Text Key: 4388595
• Report Number: 3004209178-2014-08922
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2014
• Initial Date FDA Received: 05/13/2014
• Date Device Manufactured: 10/21/2013
• 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
• Patient Age: 00038 YR