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

Model Number 97714

Device Problems Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896)

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

Event Type  Injury  

Event Description

It was reported that the patient had difficulty charging.The patient met with a company representative several times to review charging.The representative was able to get all coupling bars.The patient had never been able to consistently maintain good contact while charging.Charging took many hours and the patient was charging every few days.The battery history confirmed her report; she was not making contact.Thus, the patients device was replaced with a non-rechargeable device.Since implant of the initial device, the patient had excellent coverage and relief of her leg pain.Her back was not covered as completely as her leg.It was further reported that it was expected the patient would not have coverage of her back, per the physician.The physician had told the patient that he didn¿t think he could cover her back pain and that he was not revising the lead placement.The patient continued to have good coverage of her leg pain after the procedure.

Manufacturer Narrative

Concomitant medical products: product id 39565-65, serial# (b)(4), implanted: (b)(6) 2013, product type: lead; product id 97754, serial# (b)(4), product type: recharger; product id 97740, serial# (b)(4), product type: programmer, patient.(b)(4).Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Manufacturer Narrative

Device analysis for ins (b)(4) revealed no anomaly found.A non-standard test was done to address the complaint related with trouble recharging.Recharging of the ins was done at spacings of 0 cm, 1 cm, 2 cm and 3 cm to see how many coupling bars the ins could obtain.At 0 cm spacing there were 8 bars, at 1 cm there were 8 bars, at 2 cm there were 4 bars, and at 3 cm there were 0 bars.The same coupling was observed on a known good restore sensor ins, indicating that this ins is working correctly with a recharger.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 3691235
• MDR Text Key: 17568305
• Report Number: 3004209178-2014-04763
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2014

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: 07/28/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2014
• Initial Date FDA Received: 03/20/2014
• Supplement Dates Manufacturer Received: Not provided; 03/31/2014
• Supplement Dates FDA Received: 04/04/2014; 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 00052 YR