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

Model Number 97714

Device Problems Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: 97714, serial#: (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.

Event Description

Information was received about a patient implanted with an implantable neurostimulator (ins) for nonmalignant pain, complex ref pain syndrome type ii and spinal pain.A manufacturing representative (rep) reported that they did a physician mode recharge (prm) on one of the patients implant and the other showed end of service (eos).The rep was able to clear the por on the first implant.The rep is expected to discuss with the health care provider (hcp) about whether the patient will get another implant to replace the second one.There were no patient symptoms reported.No further patient complications have been reported as a result of this event.

Event Description

It was reported that the patient stopped using their spinal cord stimulator and was noncompliant with charging both of their implantable neurostimulator (ins)¿s.In result, they both went into overdischarge.To resolve the issue, the rep performed a trickle charge on both ins¿s successfully, a power on reset (por) message was cleared on ins (b)(4) and it was reprogrammed.It was noted that therep was not able to clear the por on the second ins ((b)(4)) because it reached the end of its service (eos).Surgical intervention did not occur, nor was it planned.There were no further complications reported or anticipated.

Manufacturer Narrative

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

Event Description

Addition information was received from a manufacturing representative.It was reported that the stimulator end of service(eos) was premature due to non-compliance from the patient.No further complications were reported as a result of this event.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6658395
• MDR Text Key: 78142824
• Report Number: 3004209178-2017-13467
• 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: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2017
• Date Device Manufactured: 01/09/2014
• 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