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

Model Number 97714

Device Problems High impedance (1291); Connection Problem (2900); Device Operates Differently Than Expected (2913)

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

Event Date 08/18/2016

Event Type  malfunction  

Event Description

The manufacturer representative (rep) reported that the patient¿s implantable neurostimulator (ins) was being replaced due to normal battery depletion and when they went to insert the leads into the new ins, the lead in the 0-7 port went in fine but the lead in the 8-15 port would not go in all the way and impedances were showing greater than 10 ,000 ohms.They put the lead from 8-15 port into the 0-7 port and it advanced all the way and impedances were fine and the lead from 0-7 port would not advance all the way when they tried it in the 8-15 port.The physician saw no visible malformations on the leads.The physician had not put the ins in the pocket at the time so nothing would have gotten into the head block that way and they tried to suction the port and wipe lead down but lead would still not advance all the way.After they switched out the ins, the leads were able to be fully inserted into the header block and the rep programmed the patient afterwards and they were getting great coverage.There were no symptoms reported.It was noted that the product would be returned.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Event Description

Additional information from the manufacturer representative reported that the 8-15 channel of the ins had an obstruction.

Manufacturer Narrative

Conclusion code no longer applies.Analysis of the implantable neurostimulator (serial number (b)(4)) found that there were no anomalies.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5912217
• MDR Text Key: 53442912
• Report Number: 3004209178-2016-17791
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 08/29/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 09/16/2016; 09/16/2016
• Supplement Dates FDA Received: 09/01/2016; 09/19/2016; 09/25/2017; 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2016
• 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: 28 YR