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

Model Number 97714

Device Problems Use of Device Problem (1670); Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/07/2016

Event Type  Injury  

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

On (b)(6) 2016, information regarding the lack of pain relief since implant was omitted and addressed in pe (b)(4).Information was received from a family member regarding a patient who was implanted with a neurostimulator for spinal pain.It was reported since implant there was difficulty getting the implantable neurostimulator (ins) charged.There was difficulty aligning the implantable neurostimulator recharger (insr) antenna and maintaining 6-8 coupling bars.There were no patient symptoms reported.Adhesive discs requested.On (b)(6) 2017, additional information was received from the patient¿s husband reporting that the patient had a ¿very very difficult time¿ trying to get the battery unit charged and they were attempting to make arrangements to get the patient a non-rechargeable battery put in.It was stated that the patient may have had a bad battery and that whatever was wrong with it, it took the patient longer to charge than the battery would last.They stated that it was ¿night-marish¿.It was indicated that the patient had not charged the battery in months now and they were sure it was dead, as they read in the manual that it could die out if the patient goes too long without charging it.The patient was redirected to follow-up with their healthcare provider.It was stated that the caller originally called in to request a manufacturing representative, as there¿s left their area.It was reviewed that patient needed to go to their hcp and have them get in contact with a manufacturing representative.No symptoms were reported and the event occurred on (b)(6) 2016.No further complications were reported/anticipated.

• 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: 6754586
• MDR Text Key: 81423160
• Report Number: 3004209178-2017-15919
• 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
• Report Date: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• 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
• Date Manufacturer Received: 07/05/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 61 YR