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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. PATIENT CABLE; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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MEDTRONIC, INC. PATIENT CABLE; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number 5433V
Medical Device Problem Code Material Fragmentation (1261)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/07/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Analysis identified that the cable connector lock was broken off.The cable was scrapped.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
The patient cable returned as an associated product and subsequently tested out of specification during manufacturer's analysis.There was no patient involvement.
 
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Brand Name
PATIENT CABLE
Common Device Name
IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key12591266
Report Number2182208-2021-03999
Device Sequence Number3255567
Product Code LWP
UDI-Device Identifier00643169703285
UDI-Public00643169703285
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
P820003
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number5433V
Device Catalogue Number5433V
Device Lot Number813620001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/28/2021
Initial Report FDA Received Date10/07/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
53401 EPG.
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