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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97714
Device Problems Battery Problem (2885); Charging Problem (2892)
Patient Problem Sleep Dysfunction (2517)
Event Date 08/09/2021
Event Type  Malfunction  
Manufacturer Narrative

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. The reason for call was pt went to the boundary waters and decided to not have their stimulation turned on. When they came back and turned the ins back on august 9th the ins would not turn on because the implant was not charged. Pt charged the implant and after 4 hours their implant was half drained. Pt ins battery use to last 2 weeks before being recharged but now the ins lasts less then a day. Pt noted they turn their stimulator off at night due to the vibrations causing them to be sleepless. Pt noted that they have sometimes increase the intensity and sometimes decreased the intensity; pt had not changed the intensity settings recently. Pt said a nurse in the pain department (b)(6) deals with the "tweaking" of the implant and dr. (b)(6) is the hcp; pt noted they had a lot of issues going on. During the call pt said they didn't have stimulation on. Pss reviewed role of a medtronic representative and pss agent emailed local field representatives advising them to reach out to patient.

 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12367178
MDR Text Key268134053
Report Number3004209178-2021-12910
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 08/25/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/25/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/14/2017
Device MODEL Number97714
Device Catalogue Number97714
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/20/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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