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

Model Number 97714

Device Problems Battery Problem (2885); Charging Problem (2892)

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

Event Date 03/14/2017

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

Information was received from a manufacturer representative regarding a patient.It was reported that the patient was charging their implantable neurostimulator (ins) too often.It was noted that the patient was recently reprogrammed for hd settings on (b)(6) 2017.The manufacturer representative stated that the patient used up a fully recharged battery in six hours.Recharge interval calculations showed that the battery should last about four to five days.It was suggested that a manufacturer representative run an impedance test and check the patient¿s recharge data using a clinician programmer.An appointment was scheduled for (b)(6) 2017.No patient symptoms were reported and there were no further complications.Indication for use is spinal pain.

Event Description

Additional information received from the manufacturer¿s representative (rep) reported the cause of the implantable neurostimulator (ins) having to be charged too often and the recharging difficulties weren¿t determined.In order to resolve the issue the consumer was switched to a lower energy setting to prevent recharging too often.The consumer¿s weight at the time of the event was unknown.No further complications were reported.

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 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: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6417779
• MDR Text Key: 70358441
• Report Number: 3004209178-2017-05940
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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
• Report Date: 03/28/2017

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: 12/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2017
• Initial Date FDA Received: 03/20/2017
• Supplement Dates Manufacturer Received: Not provided; 03/20/2017
• Supplement Dates FDA Received: 03/28/2017; 10/02/2017
• Date Device Manufactured: 01/28/2016
• 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: 69 YR