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

Model Number 97714

Device Problems Charging Problem (2892); Communication or Transmission Problem (2896); Positioning Problem (3009)

Patient Problem Weight Changes (2607)

Event Date 09/23/2016

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 patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain and rsd/causalgia-complex regional pain syndrome.The patient reported that there was poor coupling with recharging.The patient reported that she had repositioned and turned the antenna dial.The patient reported that she thought it might be due to her rural location.The patient was assisted using the antenna locate (al) feature.The patient started with 44, moved 2+ inches around above, below, left and right of incision mark with no change, turned dial and only saw 42, turned dial again and was 42 and 44, turned dial again and saw 44 in all positions.Troubleshooting did not resolve the issue.The patient reported seeing a poor coupling screen.The patient also reported that she thought the ins stuck out more than it used to, it felt bigger.The patient reported that she lost weight.No further complications anticipated.

Manufacturer Narrative

The main component of the system and other applicable components are: product id: neu_unknown, product type: unknown.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

Additional information was received from the patient in (b)(6) 2017.The patient reported that the implant was not sticking out.The patient reported that the cord was messed up to the charger.The patient reported that replacement of the antenna resolved the poor coupling and was charging now.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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6447468
• MDR Text Key: 71331909
• Report Number: 3004209178-2017-06724
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2017

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: 07/14/2017
• 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: 03/08/2017
• Initial Date FDA Received: 03/30/2017
• Supplement Dates Manufacturer Received: Not provided; 05/15/2017
• Supplement Dates FDA Received: 06/05/2017; 10/02/2017
• Date Device Manufactured: 08/14/2016
• 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: 58 YR
• Patient Weight: 41