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

Model Number 97714

Device Problems Delayed Charge Time (2586); Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

There were communication/telemetry issues.The patient can only get 2-4 bars while charging and it takes her a very long time to charge.If the patient does not press down on the device, she gets 0 bars.The patient was frustrated having spent lots of time trying to charge her device.The company representative was going to meet with the patient during a doctor¿s appointment tomorrow.The company representative was going to verify if the implantable neurostimulator (ins) was implanted too deep and see if a pocket revision was necessary.Diagnostic testing and/or troubleshooting will be performed in the future.The ins remained implanted and the patient was currently receiving effective therapy.A few days later the company representative reported that the patient was in continuous mode.The cause of the event was due to the battery placement was too deep, not related to the device.The superior aspect of the ins was more superficial than inferior aspect, so the ins was not parallel to charging paddle.The company representative helped the patient establish a charging connection but was not successful in getting more than 4 bars.The patient was scheduled for a pocket revision on (b)(6) 2014.The patient was able to keep the battery alive and getting effective therapy; otherwise happy with the device except for charging.It was confirmed that the ins was relocated to a different pocket.The ins was tested with perfect impedances.Depth was less than 1 cm.No system malfunctions were seen.No devices were explanted.The patient was doing great, receiving effective therapy, and able to recharge with full connectivity.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 97754, serial# (b)(4), product type: recharger.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 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: 4369030
• MDR Text Key: 16540343
• Report Number: 3004209178-2014-24645
• 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
• Report Date: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2014
• Date Device Manufactured: 08/08/2014
• 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