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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 97715
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problems Undesired Nerve Stimulation (1980); Dizziness (2194); Electric Shock (2554)
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that patient was feeling a shocking or "biting" sensation under the right side of their intestines. The patient indi cated that the ins was implanted in their hip on their right side.   the patient stated that the ins is implanted in their hip on their right side.  patient stated that the rep never finished adjusting the ins because the patient got"sick and lightheaded after the rep adjusted the ins "up and down 4 or 5 times. " patient stated that they received a call from mdt rep alicia (last name not provided) who advised the patient to "adjust the whole program on the machine for a whole month" and told the patient they would follow up at their hcp's office sometime in february. However, the patient stated that they continued to feel the "biting" sensation under the right side of their intestines. The patient stated that they turned off all 3 of their programs and turned off the ins completely, but they continue to feel the "biting" sensation under the right side of their intestines.

 
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Brand NameINTELLIS
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 Key11219719
MDR Text Key228474594
Report Number3004209178-2021-01253
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,Followup,Followup,Followup
Report Date 08/13/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/23/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/28/2021
Device MODEL Number97715
Device Catalogue Number97715
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/05/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/23/2021 Patient Sequence Number: 1
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